JOB DESCRIPTION

OFFICER / EXECUTIVE QUALITY ASSURANCE (VENDOR QUALIFICATION)

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
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.
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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🏢 PSA Chemicals And Pharmaceuticals
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