Dhrumil S.
Sr Manager, Digital Quality and Data Integrity at Vertex Pharmaceuticals
- Role
- Sr Manager, Digital Quality and Data Integrity for Cell & Gene Therapy at Vertex Pharmaceuticals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Dhrumil S.
15+ years of industrial experience in Computer System (CSV /IT) & Equipment validation. quality system life cycle management, and material qualification techniques to conduct research into leading-edge pharmaceutical and biotechnological scientific advances. Highly adept at generating high-quality samples and compiling sophisticated data on results of analyses. Poised, articulate and possessing good communication skills & contributed to authoring of scientific articles. Core Capabilities & Interests• Computer System/Equipment Validation and Quality System Management• ICH Q9/GAMP 5/21CFR11/ Annex 11 Guidelines• Data Integrity Implementation & DI Assessment• Validation Master Plan/Protocol Writing/Review • Regulatory Compliance• GxP /Change Control Impact Assessment• Data Compilation/Analysis
Experience
Sr Manager, Digital Quality and Data Integrity for Cell & Gene Therapy
Aug 2022 — Present · Boston, MA, US
Education
Northeastern University
Master's degree, Biotechnology
2009 — 2011
LMCP
Bachelor's degree, Pharmacy
2005 — 2009
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