MS&T - Manufacturing Investigation
Zydus Lifesciences · Panaji · onsite · Posted 21d ago
Undisclosed2–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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
Sourced from naukri
Skills
OSDmarket complaintsootdeviationUSFDACAPAChange ControloosInvestigationQMS
About Zydus Lifesciences
Zydus Lifesciences
Pharma
28k+
employees
1952
74 years old
Ahmedabad, India
India
About
Driven by a passion for innovation, making a difference in the world of healthcare
Industries
PharmaBiotech & Life sciences
Employees rate it well for
Work Culture865Work Environment456Senior Management441Salary415Job Security393
Find them on