Robert Ewing
Associate Director, Quality Engineering & Validation at Bristol Myers Squibb
- Role
- Associate Director, Quality Engineering & Validation (Qev) at Bristol Myers Squibb
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director, Quality Engineering & Validation (Qev)
Jan 2024 — Present · Bothell, WA, US
Lead the site QEV team, providing Quality Assurance oversight of environmental, equipment, utility, facility, automation / computerized systems, and process validation efforts, and related QMS records.
Skills
- Computer System Validation
- Quality Assurance
- Biopharmaceuticals
- Process Validation
- Validation
- Documentation
- Document Management
- Database Design
- Regression Testing
- System Integration Testing
- Software Documentation
- 21 Cfr Part 11
- Change Control
- Process Improvement
- V&V
- Capa
- Fda
- Gmp
- Pharmaceutical Industry
- Sop
- U.s. Food and Drug Administration (Fda)
- Standard Operating Procedure (Sop)
- Business Process Improvement
- Verification and Validation (V&V)
- U.s. Title 21 Cfr Part 11 Regulation
- Corrective and Preventive Action (Capa)
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