Roles and Responsibilities :

- Lead investigations into deviations, OOS/OOT events, market complaints, and CAPAs to identify root causes and implement corrective actions.
- Collaborate with cross-functional teams to develop and execute investigation plans, ensuring compliance with regulatory requirements (e.g., USFDA).
- Conduct analytical testing and data analysis to determine the validity of market complaints and identify trends that may impact product quality or safety.
- Develop and maintain documentation for all investigations, including incident reports, risk assessments, and corrective action plans.

Job Requirements :

- 10-14 years of experience in biopharmaceutical industry with expertise in analytical quality assurance and deviation management.
- Strong understanding of ICH guidelines on Valuable Manufacturing Practices (GMP) and Quality Management Systems (QMS).
- Experience with change control procedures related to equipment maintenance, cleaning validation, sterilization processes etc.

📌 Manager - QA (Investigation) (Gujarat)
🏢 Intas
📍 Gujarat