Role Purpose
To supervise and ensure GMP‑compliant Drug Product manufacturing operations by controlling daily production activities, guiding operators, and ensuring quality, safety, and production targets are achieved.
Role Description
- Supervise and control daily Drug Product manufacturing operations (formulation, filling, lyophilization, inspection, packaging) in accordance with SOPs, batch records, and GMP requirements.
- Lead and guide DP Operators, including task assignment, work discipline, GMP compliance, and on‑the‑job coaching.
- Ensure batch documentation, logbooks, and production records are completed accurately, reviewed, and ready for QA submission.
- Monitor production processes, identify deviations, abnormalities, or equipment issues, and coordinate immediate actions and investigations.
- Coordinate with QA, QC, Engineering, Planning, and Warehouse to ensure smooth production flow, validation readiness, and audit compliance.