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.