Rajesh Dolas
Global GMP Auditor | GMP, Regulatory Compliance and Auditing
- Role
- Global Gmp Auditor at Endo
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Rajesh Dolas
Experienced Pharmaceutical Lead Auditor with a strong understanding of quality assurance…
Experience
Global Gmp Auditor
Mar 2024 — Present · Navi Mumbai, IN
Conducted GMP audits across multiple pharmaceutical manufacturing sites, ensuring consistent adherence to global regulatory standards (e.g, USFDA, EU GMP, PIC/S). Identified systemic quality issues and trends trough meticulous analysis of audit findings, • Expertise in auditing complex quality systems including change control, deviation management, Validation (process, cleaning, equipment) and supplier qualification programme. • Effectively communicated complex audit findings and recommendations to leadership team, influencing decision making. • Implemented risk-based audit strategies, optimizing audit frequency and scope to focus on critical areas and proactively mitigate potential quality and compliance risks. • Good understanding of API manufacturing process and equipment, enabling effective assessment of compliance provided to audit findings. • Managed and maintained the audit management system, ensure accurate record keeping, timely completion of audit activities and effective tracking of CAPAs.
Education
University of Mumbai
Master of Science (M.Sc.)
2009 — 2011
Skills
- Pharmaceutical Industry
- Sop
- Hplc
- Communication, Team Player
- Glp
- Gmp
- Quality System
- Regulatory Affairs
- Quality Assurance
- Validation
- Technology Transfer
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