Rakesh Kumar Sinha
Senior Vice President & Head-Drug Product Manufacturing @ Biological E. |Vaccine, & Pharma Operations I Strategic Leader I P&L | Transforming - People, Process, & Technology |FDA Compliance |Digitization & Automation
- Role
- Senior Vice President at Biological E. Limited
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rakesh Kumar Sinha
Dynamic leader with over 32 years of experience, providing strategic direction and…
Experience
Senior Vice President
Apr 2025 — Present · Hyderabad, IN
Education
Birla Institute of Technology and Science, Pilani
Master of Science (MS), Pharmaceutical Operations & Management
2008 — 2010
Indian Institute of Technology (Banaras Hindu University), Varanasi
B.Pharma, Pharmaceutical
1989 — 1993
Skills
- Ectd
- Regulatory Submissions
- Drug Delivery
- Anda
- Cleaning Validation
- Glp
- Quality System
- V&V
- Regulatory Requirements
- Gxp
- Aseptic Processing
- Formulation
- Pharmaceutics
- Hplc
- U.s. Food and Drug Administration (Fda)
- Technology Transfer
- Generic Programming
- Standard Operating Procedure (Sop)
- Regulatory Affairs
- Lifesciences
- Quality Assurance
- 21 Cfr Part 11
- Life Sciences
- Dissolution
- Validation
- Manufacturing
- Change Control
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Good Laboratory Practice (Glp)
- Capa
- Drug Development
- Biopharmaceuticals
- Oncology
- Clinical Trials
- Quality Control
- Gmp
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