- 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
- Good documentation and investigation skills
- Robust knowledge of GMP and regulatory requirements
- Laboratory investigations
- Effective communication and cross-functional coordination
📌 QMS-QC (Pune)
🏢 Emcure
📍 Pune
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