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
Positive documentation and investigation skills
Robust knowledge of GMP and regulatory requirements
Laboratory investigations
Effective communication and cross-functional coordination
📌 Qms Qc Pune
🏢 Emcure
📍 Pune