Senior Executive - QA (Validation)

Responsibilities

• 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 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

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