2. Responsible for HVAC Qualification and re-qualification activities at site.
3. Responsible for monitoring, tracking of qualification and validation planner and compliance.
4. Responsible for Equipment qualification, validation & re-qualification activities at site.
5. Responsible for preparation of VMP and to update as per requirement.
6. Responsible for handling water system qualification & re-qualification activities.
7. Responsible for compressed air system qualification & re-qualification activities.
8. Responsible for Preparation and Review of Process Validation/Verification Protocol, Hold Time Study Protocol, Cleaning Validation/Verification Protocol and Process Validation/Verification Report, Hold Time Study Report, Cleaning Validation/ Verification Report to monitoring and sampling of validation batches.
9.
To collect the Process Validation Sample/Hold Time/Packing Validation Sample as per sampling plans from different stages and different location of process.
10. Responsibilities for facility Qualification.
11. To coordinate and execute validation activities & to ensure compliance.
12. To ensure & co-ordinate for execution of temperature mapping activities at site & its compliance.
13. Review & verification of environmental monitoring condition through BMS system.
14. Responsible for review, verification & certification of external documents such as certificates, manuals, SOPs.
15. Responsible to report near miss/unsafe condition with respect to safety.
16. Responsible to attend Safety trainings and to participate in different EHS events.