Corporate Quality Assurance

4 days ago


Mumbai, Maharashtra, India Ajanta Pharma Ltd Full time

Executive- Corporate Quality AssuranceKey Responsibilities:1. Vendor & Supplier Qualification & Documentation:Review and maintain documentation such as:Vendor Assessment Questionnaires (for Raw Material & Packing Material)Supplier Assessment Questionnaires (for Raw Material & Packing Material)Inspection ReportsVendor/Supplier Approval & Disqualification FormsCoordinate with site and head office personnel to gather required vendor/supplier documents.Organize and perform desk audits for APIs, key starting materials, and packing materials.2. Inspections & Audits:Conduct vendor inspections for:Starting materialsPacking materialsContract testing laboratoriesContract manufacturing sitesOther service providersPerform supplier inspections for raw and packing materials.Prepare and maintain audit reports and follow up on CAPA implementation.3. Material & Quality Communication:Notify Commercial and applicable site departments of any material rejections.Liaise with internal stakeholders regarding sourcing, documentation, and inspection outcomes.4. Documentation & System Management:Maintain proper control and lifecycle management of quality documents including issuance, retrieval, archival, and destruction.Manage records of vendor complaints across all sites and ensure CAPA monitoring and closure.Prepare and maintain internal Corporate QA documents.Use Document Control System (DCS) software for document issuance, retrieval, and obsolescence.Manage Master Product Number (MPN) creation, extension to other locations, and resolve source-related issues in SAP.Qualifications and Experience:Bachelor's/Master's degree in Pharmacy, Chemistry, or related science discipline.8–10 years of experience in Quality Assurance within the pharmaceutical industry.Experience in vendor/supplier qualification, audits, and regulatory compliance.



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