Akshay Raina
Ahmedabad
Summary
Innovative, Self-Driven, Goal oriented
Experienced production and Quality Management System specialist with specialization in Biopharma industry, Fermentation technology, Mammalian cell culture and MSAT related skillset. Desire to become an experienced professional in the field of Biotechnology by working in an organization that gives opportunity in the field of Process engineering and Method Optimization to achieve the desired goals.
Overview
5
5
years of professional experience
Work History
Executive
Zydus Lifesciences Limited. (Biologics Division)
07.2021 - Current
- Qualification (IQ/OQ/PQ) of BioSTAT STR Generation 3 Bioreactors and Flexsafe STR Bags
- Qualification (IQ/OQ/PQ) of BioWelder Total Containment and BioSealer TC
- Quality Management System (Handling of Investigation, CAPA, Change controls with respect to Deviations and OOS/OOT on Trackwise)
- Data analysis and Trouble shooting
- Quality risk Management of New equipment and new Product
- Scale up and MSAT of batches from 20 L Scale to 200 L Scale (Single Use Bioreactor) and 20 L Scale to 5000 L Scale (Stainless Steel Bioreactor), conducting of Process Performance Qualification batches, preparing batch data reports and daily data presentations of in process data
- Preparation of Standard Operating Procedure for new equipment and periodic reviews
- Preparation of Master Formula Record and Batch Manufacturing record of New Product
- Logic Modification of SCADA on routine trouble shooting exercise
- Daily cross functional team discussion, tracking and follow-up with Manufacturing, Warehouse, Research and Development, Quality control and quality assurance department for timely closure of all open QMS records.
Production Specialist
Dr. Reddy’s Laboratories (Biologics Division)
06.2019 - 07.2021
- Quality Management System (Handling of Investigation, CAPA, Change controls with respect to Deviations and OOS/OOT)
- Data analysis and Trouble shooting
- Preparation of Standard Operating Procedure for new equipment and periodic reviews
- Preparation of Master Formula Record and Batch Manufacturing record of New Product
- Routine upstream Batch Operation of Monoclonal Antibodies (Rituximab, Trastuzumab, Bevacizumab)
- Cross Functional Meetings for seamless batch Operations with Quality control, Quality Assurance and warehouse
- Bioreactor scale up studies (kLa studies)
- Preparation of Standard Operating Procedure for new equipment and periodic reviews.
Education
M.Sc. Microbiology -
The Maharaja Sayajirao University of Baroda
01.2019
Skills
- Single use systems
- Upstream processing
- Scale up/MSAT
- Data analysis
- Process engineering
- Interpersonal Skills
- Quality Management
- Problem Resolution
- Vendor Negotiations
- Strategy Development
- Team Player
- Research and analysis
- Project Management
- Risk Management
- Change Implementation
- Quality Management System
Accomplishments
Timely closure of all QMS related documents and achieved 100% Quality Index score in 2022-2023
Maintained the Quality Index Score of Biologics division above 90% in 2023-2024.
Languages
English (Fluent)
Hindi (Fluent)
Gujarati (Basic Level)
Marathi (Basic Level)
Age
27
Rewards And Academics
- Qualified JNU CEEB with AIR-261, State Rank-01
- Qualified GATE 2019, AIR 879.
Permanent Residence
Jammu, Jammu and Kashmir
Temporary Residence
Ahmedabad, Gujarat
Personal Information
- Relocation: Willing to relocate.
- Date of Birth: 10/30/1996
- Marital Status: Unmarried.
Disclaimer
The above information is true to the best of my knowledge.
Timeline
Executive
Zydus Lifesciences Limited. (Biologics Division)
07.2021 - Current
Production Specialist
Dr. Reddy’s Laboratories (Biologics Division)
06.2019 - 07.2021
M.Sc. Microbiology -
The Maharaja Sayajirao University of Baroda