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1. Preparation of all protocols related to qualification such as Equipment qualification (Installation qualification, Operational qualification and performance qualification etc.), Sterilization validation (Steam sterilizer, Vessel sterilization, Primary packing component sterilization, bulk sterilization, Aseptic process simulation not limited to), Utility qualifications (Water system, pure steam generator, Compressed air, Nitrogen gas, HVAC system etc.)

2. Planning, tracking and completing cleaning validation and verification study: Preparation of protocol (validation and verification) and acceptance criteria calculation, Compilation of data and preparation of report

3. Coordination with third parties for outsourced activities such as Temperature mapping, HVAC qualification, sterilization validation etc.

4. Coordination with other departments for validation activities such as QA, Warehouse, Production, Engineering, Purchase, Process/Packaging development etc.

5. Ensuring compliance of Regulatory and CGMP norms for all validation related activities.

6. To perform, plan and completed validation / qualification activities within requalification frequency as per VMP / product requirement.

7. Tracking and handling of QAMS activities such as Change control, Deviation, CAPA as applicable.

8. Tracking and updating of Validation Planner as per specified frequency.

You can also share your resume at parichayindore@lupin.com