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Key Responsibilities Execute and review Equipment Qualification (DQ/IQ/OQ/PQ) for manufacturing, packing, utilities, and laboratory equipment. Plan, execute, and review Process Validation, Cleaning Validation, Hold Time Validation, and Revalidation activities. Prepare and maintain Validation Master Plan (VMP), validation protocols, reports, and related SOPs.
Key Responsibilities Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with c GMP and regulatory requirements. Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents. Manage OOS/OOT, deviations,
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