Quality Assurance Manager (Vendor Qualification)

Job Responsibilities:

• Manage end-to-end vendor qualification and vendor management activities in compliance with regulatory and company requirements.
• Coordinate vendor audits, supplier assessments, and periodic evaluations to ensure adherence to quality standards.
• Support the implementation and maintenance of the Quality Management System (QMS), including deviations, change controls, CAPA, and risk assessments.
• Review and approve vendor-related documentation, including quality agreements, specifications, and technical documents.
• Coordinate with cross-functional teams to ensure compliance with quality and regulatory requirements.
• Support process validation and cleaning validation activities, including protocol preparation, execution, review, and report generation.
• Monitor vendor performance through quality metrics and ensure timely closure of observations and action items.
• Provide support during regulatory inspections, customer audits, and internal audits.