Naveen Kumar.
B Mobile: 9581956279
e-mail: naveenkumar.burla12@gmail.com
OBJECTIVE
A demonstrated self-starter with technical, communication and presentation skills, proven
leadership and achievement of results.
WORK EXPERIENCE
HETERO LABS LIMITED, UNIT-III April 2017 -
Present
▪ Serves as serialization expert on matrix teams for track and trace projects: actively manage / lead
in the development of project plans, project charters, setting project priorities and providing
input on timing, resources.
▪ Worked with IT infrastructure for management of global serialization process and batch reports
on Packing Lines. Acquired good knowledge in throughout the different phases in implementation
of Serialization Programs.
▪ Worked with all layers/levels in solutions designed with SAP ATTP serialization architectures
interfacing with ACG and Aseptic systems, right from technical analysis, integration &
implementation up to its successful commercialization on Packing Lines.
▪ Hands on experience in implementation of ACG Serialization project for packing and warehouse
equipment’s.
▪ Hands on experience in implementation of NKP Serialization project for packing and warehouse
equipment’s.
▪ Have good knowledge on GS1 standards for Health care products and implementation of EU-FMD
for serialization.
▪ Hands on experience in artworks review for various packaging materials in terms of compatibility
with Packaging operations and over coding requirements.
▪ Hands on experience in review of batch packing record (BPR).
▪ Developed Standard operating procedures for equipment’s routine operations.
▪ Conducts training sessions for operation of packaging and warehouse equipment’s.
▪ Review of documents (Installation, operational and performance qualification).
▪ Co-ordinate supporting functional departments for smooth production activity.
▪ Implementation of E Pedigree Serialization Project for Packaging Equipment’s at Hetero Unit-III
Site.
▪ Hands of experience in Installation and operational qualification of Track and Trace equipment’s.
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▪ Prepared and Developed the User Requirement Specifications & Validation documents covering
the below equipment’s for qualification of Packing Lines to support commercial packaging
operations for various pack designs and Track & Trace serialization requirements per worldwide
regulations.
▪ Worked with all layers/levels in solutions designed with SAP ATTP serialization architectures
interfacing with ACG & Aseptic (NKP) systems, right from technical analysis, integration &
implementation up to its successful commercialization on Packing Lines.
▪ Assists technical operations and IT teams with the IQ, OQ, & PQ validation activities associated
with serialization packaging lines and associated software systems.
▪ Have good knowledge on GS1 standards for Health care products and DSCSA compliance.
▪ Utilizes appropriate software’s & IT systems to manage key serialization project activities
effectively and managed to work with various cross-functional groups (such as Quality)
collaboratively and resolved the issues that block the timely flow of projects.
EQUIPMENT’S HANDLED
▪ 360° Inspection system (Make: NKP), 2D Barcode machine (Make: NKP), Aggregation machine
(Make: NKP), Label Inspection system (Make: NKP), Aggregation machine (Make: ACG), 360°
Inspection system (Make: ACG), Label Inspection system (Make: ACG), CPIR-XL (Make: ACG).
AUDIT EXPOSURE
● US-FDA, Customer Audits and Internal Audits.
ASSETS & SKILL SET
▪ Hands-on experience with below different software’s, operating systems and servers used for
database management (MS SQL & My SQL) for data and documentation.
- Windows 7, 10
- Windows 2012 R2, 2008 R2
- MS Office
▪ Hands-on experience with below different software’s used for creation of labels & jobs for over
printing details on packaging materials.
- Clarisoft
- Bartender
- ALD
- Zebra Designer
▪ Hands-on experience with below different printers used for over coding on different packaging
materials.
- Thermal inkjet m600 Touch Wolke printer
- Zebra printers
- Domino inkjet printers
▪ Qualification and operation of L-1 to L-3 serialization systems.
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▪ Developing new method and simplifying the procedures.
▪ Rejection control by following the error free procedures and avoid the re-working.
▪ Maintain good co-ordination with cross functional departments.
▪ Daily planning and maintaining real time documentation.
▪ Follow cGMP and safety at all stages of secondary packaging activity.
▪ Demonstrated experience in managing projects in the pharmaceutical industry.
▪ Ability to multi-task and prioritize work in a fast-paced environment.
▪ Excellent ability to work independently, evaluate situations and act appropriately.
▪ Excellent interpersonal skills to interact courteously and effectively with co-workers.
EDUCATION
⮚ Completed B.Sc with 69% at Goutham Degree College, Hyderabad, Pass out year 2015.
⮚ Completed Intermediate with 62% at Gowthami Junior College, Hanamkonda, Pass our year 2010.
⮚ Completed SSC with 70% at Vasista High School, Hanamkonda, Pass out year 2007.
COMPUTER COURSES
▪ Windows/OS installation and troubleshooting.
▪ Computer languages known: C, C++ & SQL
PERSONAL DETAILS
Name : Burla Naveen Kumar
Date of birth : 29-06-1991
Languages known : Telugu, English and Hindi
Sex : Male
Marital status : Married
Nationality : Indian
Address : S/o Chandrashekar, Flat No.: 103(A-3), Sliver springs apartments,
Quthbullapur, Hyderabad, Telangana, PIN Code-500054.
DECLARATION
I hereby declare that all the details furnished above are true to the best of my knowledge and belief.
Place: Hyderabad, India.
Date: (B. Naveen Kumar)
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