protocol-review-jobs-in-patan, patan

136 Protocol Review Jobs in Patan

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posted 1 month ago
experience4 to 8 Yrs
location
Ahmedabad, Gujarat
skills
  • Agile methodologies
  • CC
  • RTOSbased development
  • ARM CortexM
  • MCU architectures
  • Firmware version control
  • IoT protocols
  • Cloudconnected embedded devices
  • Cybersecurity
  • Secure firmware development
Job Description
As a Senior Embedded Firmware Engineer at ATRI Solutions Pvt. Ltd., you will be responsible for designing, developing, and debugging embedded firmware for microcontroller-based systems. Your key responsibilities will include: - Architecting, designing, and debugging embedded firmware for various domains such as automotive, industrial, consumer electronics, and healthcare. - Leading the firmware development lifecycle from requirement gathering to deployment and testing. - Collaborating with cross-functional teams to deliver integrated solutions and optimize embedded code for memory usage, performance, and power consumption. - Interfacing with communication protocols like UART, SPI, I2C, CAN, USB, BLE, and Ethernet. - Conducting board bring-up, hardware-software integration, and debugging using tools like oscilloscopes, logic analyzers, and JTAG. - Collaborating with system architects and project managers to ensure timely delivery and technical excellence. - Mentoring junior engineers and performing code reviews to maintain code quality and best practices. Qualifications required for this role include: - Bachelors or master's degree in Electronics, Electrical, Computer Engineering, or a related field. - 4+ years of hands-on experience in embedded firmware development. - Proficiency in C/C++, RTOS-based development (FreeRTOS, Zephyr, or similar). - Experience with ARM Cortex-M and other MCU architectures (STMicroelectronics, NXP, TI, Renesas, etc.). - Familiarity with firmware version control (Git), CI/CD, and Agile methodologies. - Strong debugging skills and understanding of low-level system behavior. - Experience in secure boot, OTA firmware update, and firmware reliability strategies is a plus. Preferred qualifications include exposure to IoT protocols such as MQTT, CoAP, LwM2M, experience with cloud-connected embedded devices, knowledge of cybersecurity and secure firmware development, as well as experience in working with medical, automotive, or industrial-grade products.,
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posted 3 weeks ago

Quality Assurance Tester II

ARCHER Transnational Systems Pvt. Ltd.
experience4 to 8 Yrs
location
Vadodara, Gujarat
skills
  • Quality Assurance
  • Test Automation
  • Selenium
  • C
  • JMeter
  • SQL
  • API Testing
  • Jenkins
  • Git
  • Web Technologies
  • TCPIP
  • xUnitnet
  • Continuous IntegrationContinuous Deployment CICD
  • Gatling
  • TestDriven Development TDD
  • BehaviorDriven Development BDD
  • SpecFlow
  • ObjectOriented Programming
  • Network Protocols HTTP
Job Description
Role Overview: As a QA Tester-II at ARCHER Systems, you will be responsible for leading quality assurance efforts across complex internal and third-party applications. Your role will involve driving the overall testing strategy with a strong emphasis on test automation to ensure software quality and meet system standards. You will work closely with agile scrum teams, collaborating with various stakeholders throughout the software development life cycle. Your passion for ensuring software quality will be showcased through the development, implementation, and continuous improvement of efficient, reliable automated test frameworks and suites. You will champion best practices in automation and proactively identify and mitigate potential risks and issues early in the development process. Your role will also involve designing, implementing, and executing comprehensive manual and automated test plans, scenarios, and cases. Key Responsibilities: - Perform quality assurance analysis and testing of complex internal and third-party business applications, focusing on test automation and ensuring software quality - Develop and maintain automation frameworks and test suites using tools like Selenium, C#, xUnit.net, and Jenkins for continuous integration/continuous deployment (CI/CD) - Review and analyze business requirements, system requirements, specifications documents, and user stories to provide timely feedback - Create detailed test plans, scenarios, and test cases - Coordinate testing activities across all phases of the software development life cycle (SDLC) - Conduct root cause analysis of defects and issues, and communicate findings clearly to relevant stakeholders - Identify, log, and track defects across multiple environments throughout the SDLC - Research, evaluate, and recommend improvements for testing tools, techniques, and methodologies - Participate in agile ceremonies to align testing efforts with team goals and objectives - Provide feedback on usability, serviceability, and quality risks - Prepare reports and documentation, including test plans, test cases, and test results - Prioritize and manage multiple tasks effectively in a fast-paced environment - Demonstrate a solid understanding of the business domain and end-user requirements Qualifications Required: - 4+ years of hands-on experience in quality assurance with a strong focus on test automation - Minimum bachelor's degree in computer science or equivalent education/work experience - Experience with performance and load testing tools (e.g., JMeter, Gatling) - Strong coding skills, preferably in .NET and C# - Strong SQL skills, preferably with Microsoft SQL Server - Experience with API testing and API test automation - Familiarity with test-driven development (TDD) and behavior-driven development (BDD) methodologies - Knowledge of software builds, testing, and CI/CD tools - Experience with testing tools and frameworks (e.g., Selenium, xUnit, Cucumber) - Strong problem-solving, analytical, and troubleshooting skills - Excellent written and verbal communication skills - Detail-oriented and thorough in triaging, analyzing, and identifying defects - Ability to take initiative, offer suggestions, and provide resolutions proactively - Passion for delivering business value and willingness to perform other assigned tasks - Ability to provide regular updates, system solutions, and communicate issues to the team lead - Constantly strive to learn new technologies and stay up-to-date in the rapidly changing industry,
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posted 1 month ago
experience8 to 12 Yrs
location
Ahmedabad, Gujarat
skills
  • Standard Operating Procedures
  • Change Control
  • CAPA
  • Document Preparation
  • CCF
  • SOP
  • Investigation
  • Risk Assessment
  • Protocol
  • Sterile Manufacturing
Job Description
As a Supervisor in the Sterile manufacturing department, your role involves preparing, reviewing, revising, controlling, and implementing standard operating procedures related to activities such as Change control and CAPA. You will be responsible for ensuring the smooth functioning of the department. Your key responsibilities will include: - Preparation, review, revision, control, and implementation of standard operating procedures for the Sterile manufacturing department - Document preparation for activities like CCF, SOP, Investigation, Risk Assessment, Protocol, etc. Qualifications required for this role: - M.Sc in Pharmacy or M.Pharm - Minimum 8 to 11 years of relevant experience in the pharmaceutical industry Kindly note that the company did not provide any additional details in the job description.,
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posted 1 month ago
experience5 to 9 Yrs
location
Ahmedabad, Gujarat
skills
  • market complaints
  • root cause analysis
  • process simplification
  • digitization
  • automation
  • knowledge sharing
  • WL Protocol Execution
  • FDA commitment
  • retrospective review
  • Material system assessment
  • SOP on QRM
  • laboratory practices
  • Microbiological excursions
  • documentation systems
  • auditinspection readiness
Job Description
You will be responsible for the following tasks as part of the role: - Execution of WL Protocol at each site - Reviewing the outcomes of protocol-based studies as outlined in the FDA commitment - Conducting protocol-based retrospective reviews of investigations (deviations, OOS and OOAL) of product batches within shelf life - Conducting protocol-based retrospective reviews of investigations related to market complaints - Developing a protocol for Material system assessment and suitability of vendors and implementing enhanced processes at all sites - Reviewing high-risk Investigation reports before batch disposition - Categorizing defects in the Visual Inspection program as critical, major, and minor - Implementing SOP on QRM for Injectable product Defect across all Amneal sites - Developing a protocol for assessment for QU authority and resources and implementing enhanced processes across all sites - Creating a protocol for assessment of laboratory practices, procedures, methods, equipment, documentation, and analyst competencies - Reviewing Microbiological excursions (Media fill, EM excursion, BET test, MLT failures) - Developing a protocol for assessment of documentation systems used throughout manufacturing and laboratory operations to determine where documentation practices are insufficient - Owning process compliance, standardization, capability, training/competency, and continuous improvement - Ensuring audit/inspection readiness - Establishing and monitoring global KPIs (e.g., investigation cycle time, overdue investigations, repeat events, CAPA effectiveness) and providing metrics and insights for Quality Management Review (QMR) - Implementing a roadmap and tools to ensure consistency in root cause analysis (5-Why, Ishikawa, FMEA, DMAIC, etc.) - Identifying and implementing process simplification, digitization, and automation opportunities - Promoting knowledge sharing across sites through Communities of Practice - Acting as the single point of accountability for the investigation process globally Please note that Amneal is an equal opportunity employer that values diversity and inclusion. They do not discriminate based on caste, religion, gender, disability, or any other legally protected status.,
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posted 2 weeks ago
experience5 to 9 Yrs
location
Gujarat
skills
  • CAPA
  • Deviation
  • GLP GDP Compliance
  • Stability Study Management
  • Data Integrity LIMS Operations
  • DeviationOOS Investigation
  • Regulatory Compliance Documentation
  • Leadership People Development
  • Laboratory Data Management
  • Stability Study Documentation
  • Specifications Test Methods Documentation
  • Analytical Method Validation Documentation
  • Change Control Management
  • Training
  • Compliance Record Management
  • Knowledge of Regulatory guidelinesRequirement
  • Analytical evaluation of vendor
  • Method Validationverification Protocol Designreview
  • GMP Compliance for Environmental Monitoring
  • Documentation Data
Job Description
As a QC Supervisor, your role involves planning and supervising preventive maintenance, calibration, and verification of QC instruments. You are responsible for ensuring the timely release of raw materials, intermediates, and packing materials according to approved specifications. It is essential for you to maintain strict compliance with GLP, safety protocols, and laboratory housekeeping standards. Your key responsibilities include: - Preparing and reviewing stability protocols - Monitoring sample charging/withdrawal and approving stability reports - Investigating deviations, OOS, OOAL, and incidents, and implementing effective CAPA - Reviewing and approving QC-related change controls, SOPs, and specifications - Conducting audit trail reviews and ensuring electronic data integrity for software-enabled instruments - Overseeing LIMS operations and ensuring accurate documentation and traceability - Identifying training needs and supporting skill development for QC personnel - Managing analytical column inventory and laboratory standards in accordance with SOPs In addition to the essential functions, you will be expected to: - Support internal/external audits and regulatory inspections - Drive continual improvement initiatives in QC processes and compliance - Perform any additional assignments allocated by QC Head/Designee Skills required for this role include: - Advanced knowledge of GLP & GDP Compliance, Stability Study Management, Data Integrity & LIMS Operations, Deviation/OOS Investigation, Regulatory Compliance & Documentation, and Leadership & People Development Other skills that would be beneficial: - Laboratory Data Management - Stability Study Documentation - Specifications & Test Methods Documentation - Analytical Method Validation Documentation - CAPA, Deviation, and Change Control Management - Training and Compliance Record Management - Knowledge of Regulatory guidelines/Requirement - Analytical evaluation of vendor - Method Validation/verification Protocol Design/review - GMP Compliance for Environmental Monitoring - Documentation & Data Integrity Practitioner While the job description does not provide additional details about the company, your role as a QC Supervisor will be crucial in ensuring the quality and compliance of the company's products.,
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posted 2 weeks ago
experience13 to 20 Yrs
location
Ankleshwar, Gujarat
skills
  • Production Planning
  • Execution
  • Manpower Management
  • Quality Assurance
  • Incident Reporting
  • Facility Maintenance
  • Change Control
  • Risk Analysis
  • QRM
  • Training Programs
  • Raw Material Management
  • SOP Compliance
  • Batch Record Review
  • Deviation Reporting
  • Validation Protocol
  • Qualification of Facilities
  • Equipment
  • Safety Procedures
  • CAPA Implementation
  • Customer Query Handling
Job Description
As the Block Head / Production Manager at Ankleshwar Unit 2, your key role involves overseeing the production planning and execution process. Your responsibilities include: - Managing the plant manpower according to production planning - Handling raw material management in alignment with production planning - Coordinating with cross-functional departments for production requirements - Ensuring documents are prepared and reviewed, and approved by QA for production of intermediates or API - Ensuring department procedures comply with system SOPs and departmental SOPs - Reviewing and ensuring completion of production batch records - Reporting and evaluating production deviations and incidents, investigating critical deviations and incidents as necessary - Maintaining cleanliness and disinfection of production facilities - Performing necessary calibrations, equipment maintenance, and record-keeping - Preparing and reviewing Validation Protocol and reports, ensuring their approval - Initiating change controls, evaluating proposed changes, and conducting risk analysis where applicable - Qualifying new or modified facilities and equipment - Updating and ensuring adherence to safety procedures - Providing and implementing CAPA - Attending and coordinating QRM activities - Updating personnel responsibilities with changes in designation, work nature, or responsibility - Attending training programs as scheduled - Providing manufacturing inputs for customer queries - Organizing disposal of unwanted materials - Conducting department training Your key responsibilities will include: - Managing and evaluating the entire production process - Contributing to production planning and budgeting - Leading and monitoring quality assessments for customer satisfaction - Maintaining a safe production environment - Coordinating with key internal and external production stakeholders Your qualifications should include a B.E. in Chemical Engineering or M.Sc with 13 to 20 years of experience in a relevant field.,
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posted 1 week ago

DGM production

Aarti Pharmalabs Ltd. (APL)
experience5 to 9 Yrs
location
Vapi, Gujarat
skills
  • Raw Material Planning
  • Change control
  • Training
  • Performance review
  • Managerial
  • Pharmaceutical API Intermediate
  • CDMO manufacturing
  • Production activities
  • Yield
  • Quality improvement
  • Production cycle time reduction
  • cGMP guidelines
Job Description
You should have experience working in a Managerial capacity in Pharmaceutical API Intermediate/CDMO manufacturing set ups. Your responsibilities will include: - Managing daily production activities according to the monthly plan - Improving and monitoring yield and quality - Ensuring raw material planning in coordination with the Stores Department - Monitoring and reducing production cycle time - Preparing monthly reconciliation reports - Effectively managing available resources and manpower - Ensuring all processes are carried out in accordance with cGMP guidelines in coordination with the Quality Assurance Department - Reviewing filled Batch Production Records (BPR) after batch completion - Reviewing BPR, Standard Operating Procedures (SOP), validation protocols, and other production-related documents - Initiating change control for any changes in production activities - Evaluating, investigating, and reporting critical deviations, Out Of Specification (OOS) results, complaints, and material returns - Providing training to production employees and reviewing performance standards Qualifications required for this role include: - BE in Chemical Engineering (Note: No additional details about the company were mentioned in the job description),
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posted 2 weeks ago
experience4 to 8 Yrs
location
Ahmedabad, All India
skills
  • Blockchain
  • Architecture
  • Development
  • Integration
  • Project Management
  • Agile Methodology
  • Distributed Ledger Technologies
  • Smart Contract Design
  • EnterpriseGrade Blockchain Integration
  • Smart Contract Development
  • Consensus Algorithms
  • Cryptographic Protocols
  • Tokenomics Models
  • Governance Frameworks
  • DeFi Projects
  • ZeroKnowledge Proofs
  • Layer2 Solutions
  • Interoperability Standards
Job Description
As the Blockchain Program Lead, you will play a crucial role in driving the organization's blockchain initiatives. Your responsibilities will include leading end-to-end execution of blockchain programs, making key architectural decisions for scalable and secure applications, supervising a team of blockchain engineers and developers, collaborating with cross-functional units to align solutions with organizational goals, overseeing smart contract development and deployment, evaluating emerging blockchain platforms for adoption opportunities, conducting security reviews and audits, managing vendor relationships, preparing technical documentation and executive-level presentations, mentoring team members, and promoting knowledge sharing. Qualifications: - Bachelor's or Master's degree in Computer Science, Engineering, or related field - 7+ years of experience in blockchain and distributed ledger technologies, with at least 2 years leading technical teams - Proficiency in Ethereum, Hyperledger, Polygon, or other major blockchain infrastructures - Strong understanding of consensus algorithms and cryptographic protocols - Demonstrated expertise in project management and agile methodology - Excellent communication and stakeholder management skills - Strong analytical and problem-solving capability Preferred Skills: - Experience in developing tokenomics models, governance frameworks, or DeFi projects - Familiarity with Zero-Knowledge Proofs, Layer-2 solutions, or interoperability standards like Polkadot or Cosmos - Prior experience in managing enterprise blockchain adoption or consortium participation This role reports to the Chief Information Officer and Chief Technology Officer. The ideal candidate for this position is passionate about leading blockchain transformation at scale and pioneering distributed innovations that align technology with enterprise goals. Compensation and Benefits: - Competitive salary - Professional training and certifications support This full-time, permanent position requires a minimum of 4 years of experience in blockchain. As the Blockchain Program Lead, you will play a crucial role in driving the organization's blockchain initiatives. Your responsibilities will include leading end-to-end execution of blockchain programs, making key architectural decisions for scalable and secure applications, supervising a team of blockchain engineers and developers, collaborating with cross-functional units to align solutions with organizational goals, overseeing smart contract development and deployment, evaluating emerging blockchain platforms for adoption opportunities, conducting security reviews and audits, managing vendor relationships, preparing technical documentation and executive-level presentations, mentoring team members, and promoting knowledge sharing. Qualifications: - Bachelor's or Master's degree in Computer Science, Engineering, or related field - 7+ years of experience in blockchain and distributed ledger technologies, with at least 2 years leading technical teams - Proficiency in Ethereum, Hyperledger, Polygon, or other major blockchain infrastructures - Strong understanding of consensus algorithms and cryptographic protocols - Demonstrated expertise in project management and agile methodology - Excellent communication and stakeholder management skills - Strong analytical and problem-solving capability Preferred Skills: - Experience in developing tokenomics models, governance frameworks, or DeFi projects - Familiarity with Zero-Knowledge Proofs, Layer-2 solutions, or interoperability standards like Polkadot or Cosmos - Prior experience in managing enterprise blockchain adoption or consortium participation This role reports to the Chief Information Officer and Chief Technology Officer. The ideal candidate for this position is passionate about leading blockchain transformation at scale and pioneering distributed innovations that align technology with enterprise goals. Compensation and Benefits: - Competitive salary - Professional training and certifications support This full-time, permanent position requires a minimum of 4 years of experience in blockchain.
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posted 2 months ago

SDET/ Sr. SDET/ SDET Lead

VOLANSYS (An ACL Digital Company)
experience3 to 7 Yrs
location
Ahmedabad, Gujarat
skills
  • Python
  • Test Methodologies
  • SDLC
  • Black Box Testing
  • Test Management Tools
  • Automation Testing
  • Data Structures
  • Automation Frameworks
  • Test Metrics
  • Networking Protocol
  • IoT
  • Performance Testing
  • Jmeter
  • Appium
  • QTP
  • Selenium
  • Cucumber
  • CICD pipelines
  • DevOps practices
  • Programming Techniques
  • BDDTDD
  • Cloudbased Testing Environments
  • SoupUI
  • Postman
  • SpecFlow
Job Description
As an SDET/ Sr. SDET/ SDET Tech. Lead at Volansys (An ACL Digital Company), your role involves designing, developing, and maintaining automated test frameworks and scripts for web, mobile, and API testing. You will ensure that the automation frameworks are scalable, maintainable, and reusable. Staying current with industry trends and best practices in automation testing and QA methodologies is essential. Your responsibilities will include reviewing and documenting test plans and test cases, working closely with cross-functional teams, participating in design and code reviews, analyzing test results, identifying defects, and generating test reports and metrics to track the quality and coverage of the automation suite. Key Responsibilities: - Design, develop, and maintain automated test frameworks and scripts for web, mobile, and API testing - Ensure scalability, maintainability, and reusability of automation frameworks - Stay updated with industry trends and best practices in automation testing and QA methodologies - Review and document test plans and test cases - Work closely with cross-functional teams to ensure comprehensive test coverage - Participate in design and code reviews from a QA perspective - Analyze test results, identify defects, and collaborate with development teams to resolve issues - Generate test reports and metrics for tracking quality and coverage Qualifications Required: - In-depth understanding of Test Methodologies, SDLC (Waterfall, Agile), STLC, Bug Life Cycle - Hands-on experience in Black Box Testing techniques - Proficiency in using Test Management Tools and Bug Tracking Tools (e.g., TestRail, HP ALM) for test report generation - Experience in Embedded firmware and hardware testing - Certification in automation testing (e.g., ISTQB Advanced Level - Test Automation Engineer) - Familiarity with CI/CD pipelines and DevOps practices - Expertise in Python-based development - Hands-on experience with Automation frameworks like Robot, GTest, py.test, etc. - Understanding of data structures, programming techniques, automation of remote data processing, and parsing input files - Experience in networking protocol, Devices, and application testing - Experience with IoT, Thread, Azure, Nest, Apple Home Kit, etc. Additional Company Details: - ACL Digital - ALTEN is the 3rd Largest Engineering services company in the world - Great Place to work certified - Acquired Si2chip Technologies, Wafer Space Semiconductor & Coqube semiconductor, Volansys Technologies - 50000+ Employees from 75 nationalities Soft Skills: - Excellent communication and Interpersonal skills - Strong analytical and problem-solving skills - Detail-oriented with a commitment to quality and precision Location: Ahmedabad (Work from Office Mandatory),
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posted 1 week ago

Lead Fire & Safety

Deepak Group Co
experience3 to 7 Yrs
location
Bharuch, Gujarat
skills
  • Fire prevention measures
  • Design
  • operation of firesafe equipment
  • Hazard identification
  • risk assessment techniques
  • Emergency Preparedness
  • Response
  • Designing
  • managing emergency response plans
  • Conducting fire drills
  • Managing emergency equipment
  • Keeping fire
  • safety appliances in working condition
  • Periodical review of applicable statutory compliance
  • Ensure compliance
  • liaison with Regulatory authorities
  • NEBOSH International General Certificate IGC
  • IOSH Managing Safely
  • HSE Auditing Certification
Job Description
As a Fire and Explosion Prevention Specialist, your role involves implementing fire prevention measures and ensuring the safe storage and handling of hazardous chemicals. Your responsibilities will include: - Designing and operating fire-safe equipment. - Utilizing hazard identification and risk assessment techniques such as PHA, HAZOP, RCA, FTA, FMEA, and SIL. - Developing and managing emergency response plans for fire incidents, chemical spills, and toxic gas leaks. - Conducting fire drills, evacuation protocols, and overseeing fire crew and Emergency Response Team (ERT) activities. - Maintaining emergency equipment like fire suppression systems, gas detectors, and personal protective equipment (PPE). - Ensuring proper functioning of safety appliances including safety showers, breathing air supply, sprinkler systems, alarm systems, fire extinguishers, MCP, fire hydrants, monitors, and fire water pumps. - Regularly reviewing and ensuring compliance with statutory regulations and fire safety codes/standards, and liaising with regulatory authorities. Qualifications required for this role include: - B.Sc. in Fire Engineering, Safety Engineering, Industrial Safety Management, or Environmental Health and Safety. - M.Sc. in Occupational Health and Safety Management or Fire Engineering. - BE in Fire Engineering. In addition to the qualifications, the following skills are necessary: - NEBOSH International General Certificate (IGC). - IOSH Managing Safely certification. - HSE Auditing Certification. This job description focuses on your responsibilities in fire prevention, emergency preparedness, and regulatory compliance within the realm of fire and explosion prevention.,
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posted 2 months ago
experience2 to 6 Yrs
location
Gujarat
skills
  • Process Validation
  • SOP
  • Regulatory
  • Documentation
  • Cleaning Validation
  • Report Compilation
  • Calibration
  • Vendor Audit
  • Qualification
  • Hold Time Validation
  • Critical Process Parameters
  • Sample Collection
  • Protocol
  • Report Validation
  • GMP Quality System
  • Internal Audits
  • Master Documents Review
  • Temperature Mapping
  • Parenteral Background
Job Description
As an Officer/Executive in the Quality Assurance Department at a company located in Bavla, Ahmedabad, your role will involve the following responsibilities: **Role Overview:** You will be responsible for Process Validation and Qualification activities in the pharmaceutical manufacturing industry. **Key Responsibilities:** - Prepare standard operating procedures for various processes - Issue controlled formats to the concerned departments - Provide necessary documents for regulatory dossier submissions - Prepare protocols for Process Validation, cleaning validation, and hold time validation studies - Execute process validation, hold time validation, and cleaning validation activities - Review protocols for validation studies - Communicate critical process parameters and hold times to production - Collect samples, submit reports, and compile summary reports for validation studies - Issue validation protocols for hold time, cleaning, and process validation - Perform any other tasks assigned by the Head of Department **Qualifications Required:** - M. Pharma/B. Pharma/M. Sc degree - Exposure in the Parenteral background is a must The company emphasizes the importance of developing, implementing, managing, auditing, and maintaining GMP Quality systems. You will also be responsible for reviewing and approving SOPs, participating in internal audits, and reviewing Master Documents like BMR, Protocols, and Reports. If you are interested in joining our organization, please send your detailed resume to Recruitment@swiss.in.,
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posted 1 month ago
experience10 to 14 Yrs
location
Gujarat
skills
  • SOPs
  • Documentation Data Review
  • Interpretation Statistical Analysis
  • Strong knowledge of cGMP
  • Warehouse Compliance Systems
  • Good Communication
  • Coordination Abilities
Job Description
You will be responsible for planning, procuring, evaluating, and controlling inventories of raw materials and packaging materials in line with production requirements. Your key responsibilities will include: - Coordinating with the Purchase department to ensure timely availability of materials. - Coordinating with Quality Control for timely release of materials as per production schedule. - Preparing, reviewing, and implementing departmental SOPs. - Training subordinates on departmental SOPs and updates. - Ensuring strict adherence to SOPs and cGMP during warehouse operations. - Preparing and submitting MIS reports as required. - Verifying and maintaining the integrity of all cGMP and statutory records. - Ensuring receipt, storage, and dispensing of materials are carried out per defined procedures, with reference to relevant MSDS and safety requirements. - Overseeing proper return or destruction of rejected materials in compliance with procedures and MSDS guidelines. - Ensuring weighing balances are verified and calibrated per SOPs. - Maintaining environmental conditions of designated storage and dispensing areas as per SOP. - Coordinating with the Engineering department to execute preventive maintenance of departmental equipment. - Ensuring calibration of standard weights, balances, and instruments is done before the due date. - Enforcing safety protocols and ensuring all team members follow defined safety measures during operations. - Monitoring receipt, storage, and issuance of engineering and miscellaneous materials as per SOPs. - Preparing and reviewing equipment qualification protocols and reports in collaboration with the Engineering department. - Assisting in conducting qualification studies and temperature mapping protocols. - Ensuring timely dispatch of finished goods to customers with proper documentation. - Maintaining overall housekeeping and upkeep of warehouse areas. - Leading and coordinating change controls, deviations, and ensuring timely closure. - Representing the department during audits and ensuring prompt compliance with audit observations. You will also have additional responsibilities, including: - Raising material/service indents and preparing Capex proposals as needed. - Managing departmental inventory effectively. - Attending technical workshops/seminars and exploring new techniques and technologies relevant to the warehouse function. Your qualifications should include: Education: - B.Sc. / B. Pharma (Preferred) - B.Com or equivalent (Acceptable) Experience: - 10-12 years of relevant experience in warehouse and distribution, preferably in a pharmaceutical or regulated industry. Skills: - Documentation & Data Review - Interpretation & Statistical Analysis - Strong knowledge of cGMP, SOPs, and warehouse compliance systems - Good communication and coordination abilities across departments,
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posted 1 week ago

Jr. Electrical Engineer

Encore Natural Polymers Pvt Ltd
experience0 to 3 Yrs
location
Ahmedabad, Gujarat
skills
  • Electrical Engineering
  • Installation
  • Maintenance
  • Repair
  • Collaboration
  • Technical Reports
  • Cost Estimation
  • Regulations
  • Evaluation
  • Research
  • Analysis
  • Safety Protocols
Job Description
As a Jr. Electrical Engineer at Encore Natural Polymer Pvt. Ltd., your role will involve assisting senior engineers in designing, developing, and testing electrical systems and components. You will be required to perform research and analysis to support electrical engineering project goals. Additionally, your responsibilities will include participating in the installation, maintenance, and repair work of electrical systems, collaborating with team members to achieve project outcomes, and reviewing and monitoring electrical equipment for maintenance needs. It will be your duty to identify engineering problems, propose effective solutions, and ensure compliance with safety protocols and regulations in all electrical activities. You will also be responsible for preparing technical reports, cost estimates, and project workflows, as well as evaluating electrical systems and recommending improvements. Key Responsibilities: - Assist senior engineers in designing, developing, and testing electrical systems and components - Perform research and analysis to support electrical engineering project goals - Participate in the installation, maintenance, and repair work of electrical systems - Collaborate with team members to achieve project outcomes - Review and monitor electrical equipment for maintenance needs - Identify engineering problems and provide effective solutions - Prepare technical reports, cost estimates, and project workflows - Ensure compliance with safety protocols and regulations in all electrical activities - Stay updated with advancements in technologies, industry standards, codes, and regulations - Evaluate electrical systems and recommend improvements Qualifications Required: - B.E, B Tech in Electrical If you are interested in this position, please share your CV with us at kpanchal@encorenaturalpolymers.com. This is a full-time, permanent role that offers benefits such as leave encashment and provident fund. The preferred education requirement is a Bachelor's degree, and the preferred experience is up to 1 year. The work location is in person.,
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posted 2 months ago
experience3 to 7 Yrs
location
Ahmedabad, Gujarat
skills
  • protocols
  • document management
  • change control
  • deviations
  • CAPA
  • training
  • Audit
  • compliance
  • kaizen
  • sterile manufacturing
  • parenteral facility
  • continuous improvements
Job Description
Role Overview: - You will be responsible for the preparation and review of master documents for sterile manufacturing in the parenteral facility. - Your role will involve preparing and reviewing protocols and reports as per requirements. - You will handle document management and preparation of BMRs, BPRs, master SOPs, etc. - Managing change control, deviations, CAPA, investigations will also be part of your responsibilities. - Providing training to subordinates, technicians, and operators in the department will be your duty. - Ensuring audit and compliance on the manufacturing shop floor. - Utilizing knowledge of kaizen and continuous improvements. Key Responsibilities: - Prepare and review master documents for sterile manufacturing. - Create protocols and reports based on requirements. - Manage document preparation including BMRs, BPRs, master SOPs, etc. - Handle change control, deviations, CAPA, investigations. - Provide training to subordinates, technicians, and operators. - Ensure audit and compliance on the manufacturing shop floor. - Implement kaizen and continuous improvement practices. Qualification Required: - B.Pharm/M.Pharm candidate with a minimum of 3-5 years of experience in manufacturing QMS/Process review/Compliance.,
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posted 2 months ago
experience22 Yrs
location
Halol, Gujarat
skills
  • Preventive Maintenance
  • HVAC
  • Facility Management
  • Energy Conservation
  • Budgeting
  • Inventory Management
  • Standardization
  • Continuous Improvement
  • Change Control
  • Engineering GMP Documents
  • Qualification Documents
  • QMS document review
  • Electrical
  • Technical Investigations
Job Description
Role Overview: You will serve as a General Manager (Engineering) with a focus on overseeing various engineering operations in a regulated market and sterile background. Your responsibilities will include signing, reviewing, and verifying engineering GMP documents, maintenance reports, qualification documents, and QMS documents. Additionally, you will handle engineering operations related to HVAC, electrical systems, and facility management, ensuring continuous improvement and adherence to quality standards. Key Responsibilities: - Authorize and oversee the signing, reviewing, and verifying of various engineering documents such as GMP documents, maintenance reports, and qualification documents - Review and close QMS documents, ensuring compliance with quality standards - Manage Halol-1 (NOSD) Engineering Operations, including HVAC, Electrical, and Facility Management activities - Approve preventive maintenance activities, equipment protocols, and SOPs - Implement measures to reduce production equipment breakdown time and ensure availability of critical utilities - Conceptualize and implement energy conservation measures for energy and water systems - Prepare annual revenue and capital budgets, ensuring expenses are within budget and implementing sanctioned capital expenditures - Standardize documentation and procedures in the engineering department to enhance efficiency - Coordinate with maintenance and production teams to improve engineering operating systems and prevent breakdowns - Track Capex and modification activities to ensure timely delivery within safety, quality, timeline, and budget parameters - Participate in technical investigations, quality council meetings, and training activities - Oversee facility management team operations and evaluate change control related to the global IT division Qualification Required: - Bachelor's degree in Electrical & Electronics Engineering - 22 to 24 years of experience in regulated markets and sterile backgrounds - Strong knowledge of GMP, QMS, and engineering practices - Experience in facility management, energy conservation, and budget management - Excellent communication and leadership skills to drive continuous improvement initiatives (Note: Additional details of the company were not provided in the job description.),
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posted 2 months ago

AI / Computer Vision Engineer

Varologic Technologies Pvt Ltd
experience1 to 5 Yrs
location
Ahmedabad, Gujarat
skills
  • debugging
  • RTOS
  • C programming
  • embedded software development
  • memory management
  • CC programming
  • microcontroller platforms experience
  • hardware bringup
  • embedded communication protocols
  • ARM CortexM
  • oscilloscopes
  • logic analyzers
  • JTAG debuggers
  • version control Git
  • lowlevel device drivers
  • interrupt handling
Job Description
As an Embedded Systems Engineer at our company, you will be responsible for firmware and driver development for embedded devices, including sensors, motor controllers, and battery management systems. Your key skills will include: - Experience with real-time operating systems (RTOS) and embedded communication protocols such as CAN, UART, SPI - Proficiency in C and C programming for resource-constrained environments - Hands-on experience with microcontroller platforms like STM32, ARM Cortex-M - Ability to perform hardware bring-up and debugging using oscilloscopes, logic analyzers, and JTAG debuggers - Strong understanding of the embedded software development lifecycle and version control (Git) - Good knowledge of low-level device drivers, interrupt handling, and memory management As an Embedded Systems Engineer, your main responsibilities will include: - Designing, implementing, and testing embedded software and firmware components - Collaborating with hardware engineers for system integration and validation - Debugging and optimizing code for performance, power, and memory usage - Participating in design reviews, code reviews, and maintaining documentation - Supporting production and post-production debugging and issue resolution - Following quality assurance processes and maintaining coding standards - Effectively communicating technical concepts and collaborating within cross-functional teams If you have a degree in Electronics/Embedded Systems or related field, strong C/C programming skills, and experience with microcontroller platforms like STM32/ARM, then this position is perfect for you. The location for this position is Ahmedabad, Gujarat, India. We are excited to welcome talented individuals with 1-3 years of experience in embedded systems to join our team of professionals.,
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posted 2 weeks ago

Embedded Programmer

Spectra Technovision (India) Pvt. Ltd.
experience3 to 7 Yrs
location
Ahmedabad, Gujarat
skills
  • C
  • Microcontrollers
  • Multithreading
  • Assembly language
  • SPI
  • I2C
  • Ethernet
  • Software development methodologies
  • Debugging
  • CC
  • Embedded systems architecture
  • Realtime operating systems
  • Hardwaresoftware interfaces
  • Communication protocols UART
  • Version control systems
  • Problemsolving
Job Description
Role Overview: As an Embedded Programmer, you will be responsible for designing, developing, testing, and debugging embedded systems software and firmware. You will collaborate with cross-functional teams to define system requirements, architect solutions, and implement code for various embedded applications. This role offers a challenging and rewarding opportunity to contribute to the development of cutting-edge embedded systems. Key Responsibilities: - Design and develop embedded software and firmware for various embedded systems, including microcontrollers, microprocessors, and digital signal processors. - Collaborate with hardware engineers and system architects to define system requirements, hardware-software interfaces, and system integration. - Develop low-level device drivers and interface software to facilitate communication between embedded systems and external peripherals. - Write efficient, reliable, and scalable code for real-time operating systems (RTOS) and bare-metal environments. - Conduct thorough testing, verification, and debugging of embedded software to ensure functionality, performance, and quality. - Perform code reviews and provide constructive feedback to team members to maintain code quality and ensure adherence to coding standards. - Optimize system performance, memory utilization, and power consumption for embedded applications. - Stay updated with the latest technologies, tools, and trends in embedded systems development and propose innovative solutions to improve system capabilities. - Collaborate with cross-functional teams to support product development and meet project timelines. - Document design specifications, software architecture, and technical specifications for knowledge sharing and future maintenance. Qualifications Required: - Bachelor's degree in Electronics/Electrical/IC Engineering, or a related field. A Master's degree is a plus. - 3+ years of experience in embedded software development. - Knowledge of C, Microcontrollers, C/C++, Multithreading, and assembly language for embedded systems. - Strong understanding of embedded systems architecture, real-time operating systems, and hardware-software interfaces. - Experience with microcontrollers, microprocessors, and embedded development tools. - Familiarity with communication protocols such as UART, SPI, I2C, and Ethernet. - Proficiency in software development methodologies, version control systems, and bug tracking tools. - Excellent problem-solving skills and the ability to debug complex software and hardware issues. - Strong analytical and organizational skills with effective verbal and written communication abilities. Note: The company offers a competitive salary, comprehensive benefits package, a dynamic work environment with growth opportunities, and professional development support.,
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posted 2 months ago

Quality Assurance (IPQA - Injectable)

Lincoln Pharmaceuticals Ltd
experience2 to 6 Yrs
location
Gujarat
skills
  • Quality Assurance
  • Batch Manufacturing
  • SOP
  • Environmental Monitoring
  • QC
  • Process Validation
  • Protocol
  • Warehouse Management
  • Filling
  • Batch Packing Records
  • Inprocess Checks
  • QA SOPs
  • Batch Release Procedure
  • Micro Data
  • Aseptic Areas
  • Daily Log Card
  • Packing Area
Job Description
Role Overview: As a Quality Assurance professional at our company, your primary responsibility will be to ensure the online documentation of batch manufacturing and batch packing records. You will also be in charge of carrying out in-process checks of pre-determined process parameters as per BMR/BPR and withdrawing in-process/FP/Reference & stability samples following SOP. Additionally, monitoring the environmental condition of critical areas and reviewing & approving QA SOPs will fall under your purview. Key Responsibilities: - Ensure online documentation of batch manufacturing and batch packing record - Carry out in-process checks of pre-determined process parameters as per BMR/BPR - Withdraw in-process/FP/Reference & stability samples as per SOP - Monitor environmental condition of critical areas - Review & approve QA SOPs - Ensure the batch release procedure & review BMR/BPR/QC & Micro data - Handle Aseptic Areas - Participate and execute process validation as per protocol - Ensure and verify online recording for daily log card in warehouse, Mfg., Filling, and packing area Qualifications: - B.Sc., M.Sc., B.Pharm / M.Pharm (Note: No additional company details were provided in the job description),
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posted 2 months ago
experience12 to 16 Yrs
location
Ahmedabad, Gujarat
skills
  • manufacturing
  • preparation
  • control
  • Document management
  • Deviations
  • CAPA
  • Investigation
  • production planning
  • cGMP
  • training
  • CGMP compliance
  • supervising
  • production activities
  • reviewing
  • maintaining online documents
  • revision
  • implementation of standard operating procedures
  • master documents of production
  • Protocols
  • reports
  • handling of Change Control
  • line clearance activity
  • daily production report
  • validation
  • calibration of equipments
  • GDP
  • discipline
  • logbooks
Job Description
Role Overview: As a Production Supervisor in the manufacturing area of multiple assigned manufacturing lines, your primary responsibility will be to ensure CGMP compliance and supervise overall production activities. You will also be required to review and maintain online documents. Key Responsibilities: - Prepare, review, revise, control, and implement standard operating procedures. - Review and prepare master documents of production. - Prepare and review protocols and reports according to requirements. - Manage documents like BMRs, BPRs, Master SOPs, etc. - Handle Change Control, Deviations, CAPA, Investigations, etc. - Conduct line clearance activities before manufacturing, filling, capping, and packing operations. - Generate general purchase indents for departmental items. - Plan production on a monthly and daily basis based on material availability. - Prepare daily production reports. - Ensure all equipment and lines are validated and calibrated. - Maintain cGMP, GDP, and discipline in the department. - Ensure compliance and discipline within the team. - Create makeshift schedules as needed. - Check and maintain records and logbooks related to manufacturing, filling, and sterilization of equipment. Additional Responsibilities: - Provide training to subordinates, technicians, and operators. - Perform activities as per the requirement of the HOD. - Attend training sessions as per the schedule and ensure training compliance. Qualifications Required: - Bachelor's Degree (BA/BS) in B. Pharm is required. - Master's Degree (MS/MA) in M. Pharm is preferred. - Master's Degree (MS/MA) in M. Sc. is preferred. (Note: No additional details about the company were provided in the job description.),
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posted 2 months ago

Executive QC Tech Writer

Amneal Pharmaceuticals
experience4 to 8 Yrs
location
Ahmedabad, Gujarat
skills
  • Validation
  • Verification
  • Specifications
  • Change Control
  • Stability Testing
  • SOPs
  • Analytical Method Transfer
  • Reviewing Protocols
  • Reviewing Reports
  • Methods of Analysis
  • USP Revisions
Job Description
Role Overview: You will be responsible for preparing and reviewing analytical method transfer/validation/verification protocols and reports. Additionally, you will prepare and review specifications/methods of analysis for various materials and testing processes. You will also be involved in preparing and reviewing justification reports for reducing tests in different testing phases. Monitoring compliance with USP revisions and managing change control for documents will be part of your responsibilities. Moreover, you will prepare and review various reports such as stability time point reduction, enhanced reduced testing, stability summary, and SOPs. Key Responsibilities: - Prepare and review analytical method transfer/validation/verification protocols and reports - Review specifications/methods of analysis for various materials and testing processes - Prepare and review justification reports for reducing tests in different testing phases - Monitor compliance with USP revisions - Manage change control for documents - Prepare and review various reports such as stability time point reduction, enhanced reduced testing, stability summary, and SOPs Qualifications Required: - M- Pharmacy - M. Sc. Chemistry,
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