Nivedita Sharma
Khargone
Summary
Production Specialist in Drug Substance Manufacturing with over 6 years of experience in Upstream Bioprocessing, demonstrating expertise in Quality Management Systems, CAPA, and Change Control to enhance compliance and operational efficiency.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Production Specialist
Dr Reddy's Laboratories
09.2023 - Current
- Oversaw production of Darbepoetin Alpha using mammalian cell culture platform.
- Managed batch processes including fermenter setup, media preparation, inoculation, and harvesting.
- Operated 200L and 50L bioreactors alongside centrifuges and blood gas analyzers.
- Implemented cleaning validation protocols for bioreactors to ensure compliance.
- Prepared Change Control documents, conducted risk assessments, and managed CAPA processes.
- Reviewed and approved Standard Operating Procedures and Batch Production Records.
- Conducted OOT and OOS investigations, implementing corrective actions as needed.
- Coordinated with cross-functional teams to meet production schedules effectively.
Associate
Stelis Biopharma
10.2021 - 09.2023
- Produced vaccines via mammalian cell culture platform and Insulin Glargine synthesis.
- Managed operations of 1KL SS Fermenter, media vessels, homogenizers, and continuous centrifuges.
- Prepared End of Production Cell Bank (EOPCB) to ensure consistent quality.
- Qualified equipment including autoclaves, tube sealers, welders, hot air ovens, and dual refrigerators.
- Conducted computer system validation for autoclaves, UV spectrophotometers, and filter integrity machines.
- Executed document preparation in E-Val for GAMP Category compliance under 21 CFR Part 11.
- Reviewed manufacturing documentation such as Batch Manufacturing Records and Standard Operating Procedures.
- Implemented electronic logbooks to streamline documentation processes.
Executive
Biocon Biologics
08.2019 - 10.2021
- Oversaw microbial fermentation, cell lysis, IB isolation, and IB washing for PEG-GCSF production.
- Executed GMP-compliant manufacturing batches in accordance with production schedule at FDA-approved facility.
- Conducted SAP activities, including batch creation, consumption, declaration, and dispensing operations.
- Prepared and reviewed manufacturing documentation, including Batch Manufacturing Records and Standard Operating Procedures.
- Managed QMS components such as deviations, CAPA, change control, and cleaning validation protocols.
- Coordinated with cross-functional teams to ensure timely production of batches by issuing BMRs.
Education
Master of Technology - Pharmaceutical Operations and Management
BITS Pilani Work Integrated Learning Programme
WILP01.2024
B.E - Biotechnology
B. M. S. College of Engineering
Bangalore01.2017
Skills
- Equipment qualification
- Quality management system
- Deviation
- Change Control
- CAPA
- Risk assessment
- Upstream manufacturing
- validation
- Computerized system validation (CSV)
- Bioreactor operation
- GMP compliance
- Documentation management
- Team coordination
Certification
KGI Certificate Program (Biosciences), Biocon Academy
Disclaimer
I hereby state that all the information noted above is accurate to the best of my beliefs and I take full responsibility for the correctness of the information.
Location
Hyderabad, Telangana, India
Personal Information
- Total Experience: 6+ years
- Date of Birth: 05/08/95
Languages
Hindi
First Language
English
Advanced (C1)
C1
Accomplishments
- Successful execution of 720-Day Darbepoetin Campaign with 95% success rate along with 222.469 grams of Darbepoetin Alfa with a revenue potential of "Rupee 220 Crores".
Timeline
Production Specialist
Dr Reddy's Laboratories
09.2023 - Current
Associate
Stelis Biopharma
10.2021 - 09.2023
Executive
Biocon Biologics
08.2019 - 10.2021
Master of Technology - Pharmaceutical Operations and Management
BITS Pilani Work Integrated Learning Programme
B.E - Biotechnology
B. M. S. College of Engineering
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