Department: Quality Assurance – Corporate Quality Assurance
Position: Officer / Executive – QA (Vendor Qualification)
Reporting To: AGM – Corporate Quality Assurance
Location: Head Office
Number of Positions: 01
Industry: Pharmaceutical – Finished Formulations
1. JOB PURPOSE
To manage and coordinate the Vendor Qualification and Vendor Quality Management System for vendors/suppliers of APIs, excipients, packaging materials, contract service providers and other quality-critical materials/services, ensuring compliance with applicable GMP, regulatory requirements and company SOPs.
The incumbent will be responsible for vendor evaluation, qualification, documentation, periodic requalification, quality audits, CAPA follow-up and maintenance of approved vendor records.
2. KEY RESPONSIBILITIES
A. Vendor Qualification & Evaluation
- Coordinate the complete Vendor Qualification process from initial evaluation through approval and periodic requalification.
- Review and evaluate vendor qualification documents,
questionnaires and supporting records.
- Coordinate collection and review of:
- GMP certificates
- Manufacturing/Business licenses
- ISO certificates
- Product specifications
- COA formats
- DMF/technical documents, wherever applicable
- TSE/BSE declarations
- Non-GMO declarations
- Allergen/Gluten-free declarations
- Nitrosamine statements
- Elemental impurity declarations
- Residual solvent declarations
- Regulatory approvals/certificates
- Quality manuals and other relevant quality documents.
- Evaluate vendor compliance against approved qualification criteria and SOP requirements.
- Prepare/review Vendor Qualification Reports (VQR) and recommend qualification status to the concerned authority.
- Maintain and update the Approved Vendor List (AVL) under the direction of CQA.
B. Vendor Audit Management
- Coordinate in office, remote and desktop vendor audits as per approved audit plans.
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