Melanie Gatzke
- Role
- Associate Director Quality Assurance at GSK
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Melanie Gatzke
Quality Assurance professional with 20+ years experience and education in the…
Experience
Associate Director Quality Assurance
Nov 2022 — Present
Skills
- Good Laboratory Practice (Glp)
- U.s. Food and Drug Administration (Fda)
- Glp
- Laboratory Information Management System (Lims)
- Fda Gmp
- Trackwise
- Biopharmaceuticals
- Computer System Validation
- Hplc
- Quality Assurance
- Validation
- Fda
- Deviations
- Gmp
- Purification
- Corrective and Preventive Action (Capa)
- Pharmaceutical Industry
- Chromatography
- Change Control
- Technology Transfer
- Cgmp Manufacturing
- V&V
- Lims
- Biotechnology
- Standard Operating Procedure (Sop)
- U.s. Title 21 Cfr Part 11 Regulation
- Sop
- Quality System
- 21 Cfr Part 11
- Capa
- Cleaning Validation
- Cgmp Practices
- Aseptic Technique
- Gxp
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