Samir Shah
Director, Analytical Strategy & Operations GMP Lab Systems Bristol-Myers Squibb
- Role
- Analytical Stratey & Operation Compliance Leader at Bristol Myers Squibb
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Samir Shah
A dedicated quality & compliance oriented leader with extensive experience within the…
Experience
Analytical Stratey & Operation Compliance Leader
Aug 2019 — Present · New Brunswick, NJ, US
Education
M. S. University of Baroda
Ph. D.
1984 — 1993
Skills
- Quality Control
- Gmp
- Conflict Management
- Good Laboratory Practice (Glp)
- Regulatory Affairs
- Corrective and Preventive Action (Capa)
- Investigation
- Usp <61> and <62>; Method Suitability
- Fda
- Process and Procedures Harmonization
- Cmc Regulatory Affairs
- Global Cross Functional Team Lead
- Technology Transfer
- Management
- Team Building
- Talent Acquisition
- Life Sciences
- Pharmaceutical Microbiology
- Api Supplier Audit
- R&D
- Rapid Microbiology Method Validation
- Training & Development
- Microbiology
- Glp
- Contract Laboratory Audit
- Biotechnology
- Research and Development (R&D)
- Usp <51> Antimicrobial Effectiveness Testing
- New Business Development
- Drug Development
- Quality Assurance
- Due Diligence & Gap Assessment in New Product Acquistioin
- Test Method Validation
- U.s. Title 21 Cfr Part 11 Regulation
- Medical Devices
- Capa
- U.s. Food and Drug Administration (Fda)
- Audit & Training
- Usp Antibiotic Assays
- Process Excellence
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