Corporate Quality Assurance

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.