QMS-QC

• 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
• Strong knowledge of GMP and regulatory requirements
• Laboratory investigations
• Effective communication and cross-functional coordination