- Change Control processes, including impact assessment, approval, and closure.
- Preparation and review of quality documents such as SOPs, STPs, protocols, and reports.
- CAPA management, ensuring timely closure and effectiveness checks.
- Handling and monitoring deviation investigations, OOS/OOT, Lab events, root cause analysis (RCA) and implementation of CAPA
- Supporting internal and external audits, regulatory inspections, and compliance activities.
- Monitoring quality metrics and trends for continuous improvement.
- Ensuring compliance with GMP, GLP, and regulatory guidelines (WHO, MHRA, USFDA etc.).
Key Skills Required:
- Experience in deviation, CAPA, and change control handling
- Valuable documentation and investigation skills
- Strong knowledge of GMP and regulatory requirements
- Laboratory investigations
- Effective communication and cross-functional coordination
Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education UG: B.Pharma in Any Specialization, B.Sc in Any Specialization PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Pharmacy read more
Key Skills Skills highlighted with ‘‘ are preferred keyskills CapaLab QCChange ControlDeviation Management InvestigationGMP
📌 QMS-QC (Pune)
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📍 Pune