Lead QMS for Drug Product Manufacturing

Job title: Lead QMS for Drug Product Manufacturing

Job Description

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, CAPA management, Risk assessments, change controls, protocols, reports, discrepancies, batch 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.

Qualifications

• Minimum 10+ years of experience with qualification in B.Pharmacy/M.Pharmacy/B.Tech/M.Tech biotechnology