- Supervise day-to-day QA activities for the Injection/Parenteral manufacturing facility.
- Review and approve BMR/BPR, SOPs, specifications, protocols and other GMP documents.
- Ensure compliance with cGMP, GLP and applicable regulatory requirements.
- Handle IPQA activities for manufacturing and packing operations.
- Review and manage deviations, OOS/OOT, CAPA and change controls.
- Coordinate QMS activities, investigations and effectiveness checks.
- Review validation and qualification documents and protocols.
- Ensure proper implementation of line clearance, in-process checks and area controls.
- Support media fill,
aseptic process simulation and environmental monitoring activities.
- Participate in internal, customer and regulatory audits and ensure timely closure of observations.
- Review batch documentation and support batch release activities.
- Ensure proper data integrity and documentation practices across QA operations.
- Lead and guide the QA team and coordinate with Production, QC and Engineering departments.
Required Experience:
- Strong hands-on experience in Injection/Parenteral QA.
- Valuable knowledge of aseptic manufacturing, sterilization and GMP compliance.
- Experience in QMS, validation, deviation, CAPA and audit handling preferred.