Job Description
Evaluate and qualify new vendors based on product, service, and compliance requirements.
Conduct vendor audits (onsite or remote) to assess quality systems and GMP compliance.
Maintain and update the Approved Vendor List (AVL) and vendor files/documentation.
Review and manage vendor questionnaires, quality agreements, and technical documentation.
Coordinate with internal stakeholders for vendor approval, risk assessments, and change control.
Track and ensure timely completion of requalification and periodic review of existing vendors.
Support supplier-related investigations, CAPAs, and non-conformance issues.
Ensure all vendor-related activities comply with applicable regulatory and internal standards (e.g., GMP, ISO, ICH).
Participate in cross-functional meetings regarding supplier performance and quality issues.