- Preparation and Review of Validation and Qualification related SOPs.
- Execution and verification of Qualification Activity at the departments levels
- 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.
- Preparation and review of Validation and Qualification related Protocols and Reports.
- To investigate, evaluate and conclude the non-conformance / deviation related to validation and qualification.
- To prepare Annual Validation Master Planner and to track and update the same, time to time.
- Issuance and control of Validation and Qualification related documents.
- Preparation, review and execution Cleaning Validation protocol and report.
- Preparation, review and execution Process Validation protocol and report.
- To review the protocols and reports for the Microbiological related testing and Analytical Method validation related activities of QC Laboratory.
- To ensure the allotment of Equipment ID to all current equipment to be installed.
- To ensure the Validation and Calibration Status of the equipment at the Site.
- Preparation of Media Fill Protocols and Reports.
- To participate in Media Fill activities and ensure the review and compliance of the activity as per the Batch Records and Protocols
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