Job summary
We are looking for a meticulous professional to lead QMS of drug product manufacturing, ensuring adherence to Current Good Manufacturing Practice (cGMP) and safety norms.
Roles & Responsibilities
- Should be capable of leading the team towards QMS elements which includes handling of deviations, OOS, market complaints,ꃊPA management, Risk assessments, change controls, protocols, reports, discrepancies,ꂺtch and packaging records closures.
- Driving the improvement projects in the drug product.
- Should be leading the team for All time audit readiness and should be writing the responses to audit observations.
- Reviewing and approving SOPs, protocols, reports, discrepancies, change requests, CAPA (Corrective and Preventive Actions), QRM (Quality Risk Management), and batch and packaging records.
- Collaborating with cross-functional departments to close discrepancies and implement corrective actions, ensuring compliance with relevant GMP (Good Manufacturing Practices), safety standards, and SOPs for designated manufacturing equipment.
- Completing batch documentation in compliance with GMP, collecting and maintaining data, and participating/leading in quality and safety investigations to address and improve CAPA for drug product manufacturing.
- Engaging in continuous improvement activities, adhering to safety rules, and reporting any unsafe matters or near misses/accidents.
Minimum 10+ years of experience with qualification in B.Pharmacy/M.Pharmacy/B.Tech/M.Tech biotechnology
