Job responsibility. "• To ensure cGMP compliance at shop floor during manufacturing of vaccines and bio similar.
- Preparation, Execution and compilation of validation activities pertaining to:
- Qualification (IQ, OQ and PQ) of current equipments and Utilities (such as Water System, HVAC System, Pure Steam, Compressed Air).
- Periodic re-qualification of existing equipments and critical systems.
- Area Qualification.
- Coordination with External service provider for Execution of Qualification activity.
- Coordination for execution of CAPA plan/risk mitigation plan,
shutdown and to ensure implementation of corrective and preventive action related to qualification activity • Execution and compilation of reports of planner pertaining to qualification/validation and calibration / preventive maintenance activities as per established schedule.
- Maintain qualification document with proper filing and retrieval of same as and when.
- Preparation of Purchase Indent.
- To initiate change control and prepare documents related to qualification activity.
- To prepare and follow Annual validation Planner.
- Preparation/revision of SOP’s related to Qualification & Validation and validation master plan • Report any non-conformance to In-charge/ HOD /Designee if any."