05 Oct
|
Zydus Lifesciences
|
South Goa
05 Oct
Zydus Lifesciences
South Goa
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