Kollepara Durgakumar
Senior CSV & Compliance Validation Expert | GxP | FDA 21 CFR Part 11 | Risk-Based Validation | Pharma & Life Sciences
- Role
- Associate Manager at 辉瑞
- Location
- Visakhapatnam, AP, IN
- LinkedIn followers
- 500 followers
About Kollepara Durgakumar
Experienced Computerized System Validation (CSV) and GxP Compliance professional with…
Experience
Associate Manager
Jan 2013 — Present · Visakhapatnam, IN
Led CSV and compliance validation projects, ensuring 100% FDA/EU regulatory compliance. Managed validation lifecycle (IQ, OQ, PQ), risk-based validation, and audit readiness for GxP systems. Developed and reviewed URS, FRS, Risk Assessments, Traceability Matrix, Validation Plans. Implemented CAPA and Change Control, improving compliance efficiency by 30%. Provided subject matter expertise on Kneat, TrackWise, LIMS, Document Management Systems (PDOCS). Led regulatory audit remediations, successfully clearing 5 USFDA audits. Managed computerized system validation (CSV) and quality compliance for lab & process equipment. Conducted GAP analysis, vendor audits, and risk assessments to align with FDA 21 CFR Part 11, GMP, and EU Annex 11. Spearheaded CAPA investigations, Change Control implementation, and FDA audit preparations. Worked with PI Historian, Delta V, Kneat, QMS, and GxP business applications. Developed and reviewed GAMP 5 validation documentation for IT and lab systems.
Education
Andhra University
Bachelor of Science - BS
2001 — 2004
Andhra University
Master of Science - MS
2005 — 2007
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