Sandra Lueken
- Role
- Vice President, Head of Quality and Regulatory at Selkirk Pharma
- Location
- Winston-Salem, NC, US
- LinkedIn followers
- 500 followers
About Sandra Lueken
With over 20 years of industry experience, my background includes a full drug…
Experience
Vice President, Head of Quality and Regulatory
May 2022 — Present
Education
University of Arizona - Eller College of Management
MBA
1999 — 2001
University of Arizona
Bachelors, Biochemistry
1994 — 1996
Skills
- Cgmp
- V&V
- Fda
- Biopharmaceuticals
- Standard Operating Procedure (Sop)
- Corrective and Preventive Action (Capa)
- Pharmaceuticals
- Change Control
- Cleaning Validation
- Technology Transfer
- Capa
- Glp
- Aseptic Processing
- Quality System
- Validation
- Sop
- Lims
- Biotechnology
- Quality Assurance
- Process Validation
- Regulatory Affairs
- Pharmaceutical Industry
- Gxp
- Quality Systems
- Continuous Improvement
- 21 Cfr Part 11
- Verification and Validation (V&V)
- U.s. Title 21 Cfr Part 11 Regulation
- Gmp
- U.s. Food and Drug Administration (Fda)
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