Mangesh Dhuri
CSV/CSA | IT Quality | GxP Compliance | Digitalization | QMS & Data Integrity | GAMP 5 | 21 CFR Part 11
- Role
- Senior Validation Engineer at AstraZeneca
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Mangesh Dhuri
M.Sc. Organic Chemistry: Result oriented professional with 15 years of pharmaceutical experience in ITQA-CSV, Quality compliance & Quality control function acquired through multiple roles, in highly regulated environment.Area of expertise:1) Handling quality operations–Deviation, Change control etc.2) Computer System Validation (CSV),IT-Compliance.3) Qualification Expert: New Lab Setup and Equipment/Instrument lifecycle.4) Leading global projects from US and Belgium site for end-to-end progress with strict time deliverables.5) Third party Management. 6) Review of data with DI & Compliance with ALCOA++ Principles.7) Conduct scheduled internal audit/Data Integrity audit & Support sites for HA audit readiness.8) Proficient in electronic systems such as Track wise® for Quality records, eLIMS for Reporting data management, eLN for Raw data management, TruVault Veeva for Document management, SUMMIT for training, CisPro for inventory management & ECMMS for LCM of Instruments, Validator for CSV.
Experience
Senior Validation Engineer
Jan 2026 — Present · Bengaluru, IN
Education
University of pune
MSc, Organic Chemistry
2007 — 2009
Shivaji University, Kolhapur
Bachelor's degree, Chemistry
2004 — 2007
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