Preparation and Review of Validation and Qualification related SOP's. 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 new 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. Supportive role of IPQA team. To perform any other work as assigned by the Head of department.
