Position Summary:-
The Quality Event Investigation Manager is a key role within the Quality Organization, responsible for leading and governing the endtoend investigation of quality events in a biologics manufacturing workplace. This role ensures robust root cause analysis, CAPA implementation, product and patient impact assessments, and timely regulatory reporting. The position serves as the primary Quality representative and frontface during regulatory agency interactions related to investigations.

Key Responsibilities as Quality Event Management & Investigations:-

- Lead investigations for deviations, OOS/OOT results, manufacturing excursions, atypical events, and product quality complaints.
- Ensure investigations are scientifically sound, timely, and compliant with global regulatory requirements and expectations.




- Drive consistent use of root cause analysis tools such as 5-Why, Fishbone, and Fault Tree Analysis.
- Identify and challenge root causes to ensure data-driven conclusions addressing technical, procedural, human, and systemic factors.
- Review, approve, and monitor CAPAs, ensuring effectiveness checks and sustainable corrective actions.
- Conduct quality, patient safety, data integrity, validation, stability, and regulatory impact assessments, including reporting evaluations.
- Serve as the Quality lead during regulatory inspections, presenting investigation outcomes, risk assessments, and CAPA strategies to health authorities.

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