About the role
1. Preparation and Review of Validation and Qualification related SOP’s.
2. Execution and verification of Qualification Activity at the departments levels
3. To ensure the preparation and Review of URS/DQ/IQ/OQ/PQ related to all
new system and equipment to be installed at the site.
4. Preparation and review of Validation and Qualification related Protocols and
Reports.
5. To investigate, evaluate and conclude the non-conformance / deviation
related to validation and qualification.
6. To prepare Annual Validation Master Planner and to track and update the
same, time to time.
7. Issuance and control of Validation and Qualification related documents.
8. Preparation, review and execution Cleaning Validation protocol and report.
9. Preparation, review and execution Process Validation protocol and report.
10. To review the protocols and reports for the Microbiological related testing
and Analytical Method validation related activities of QC Laboratory.
11. To ensure the allotment of Equipment ID to all new equipment to be
installed.
12. To ensure the Validation and Calibration Status of the equipment at the Site.
13. Preparation of Media Fill Protocols and Reports.
14. To participate in Media Fill activities and ensure the review and compliance
of the activity as per the Batch Records and Protocols
15. To perform any other work as assigned by the Head of department.