
Corporate Quality Assurance
7 hours ago
Executive- Corporate Quality Assurance
Key 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 Reports
- Vendor/Supplier Approval & Disqualification Forms
- Coordinate 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 materials
- Packing materials
- Contract testing laboratories
- Contract manufacturing sites
- Other service providers
- Perform 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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