- Lead complex investigations of production deviations, batch failures, and non-conformances.

- Perform root cause analysis using structured methodologies (e.g., Fishbone, 5 Whys, FMEA).

- Develop, implement, and monitor corrective and preventive actions (CAPA).

- Ensure investigation reports are accurate, comprehensive, and compliant with GMP, FDA, EMA, and ICH guidelines.

- Collaborate with Production, QA, QC, Engineering, and Supply Chain teams to resolve systemic issues.

- Provide guidance and mentorship to junior investigators and production staff.

- Support regulatory inspections and client audits by presenting investigation outcomes and CAPA effectiveness.

- Drive continuous improvement initiatives to enhance manufacturing robustness and reduce deviations.

- Ensure timely closure of investigations to avoid delays in batch disposition.

- Contribute to risk assessments and change control processes.

- Investigations related to OOS/OOT

📌 MS&T - Manufacturing Investigation (South Goa)
🏢 Zydus Lifesciences
📍 South Goa