Executive, Quality Assurance-Quality Management System (QMS)

Job Description

To ensure that all vendors supplying materials (raw materials, packaging materials, outsourced manufacturing, and service providers) meet the company’s quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities Vendor Qualification Process: Initiate and coordinate vendor qualification activities for new and existing vendors. Prepare and maintain vendor qualification dossiers and files. Coordinate with procurement and other departments for vendor data and documentation. Ensure vendors comply with GMP, regulatory requirements, and company quality standards. Document Review: Review and evaluate vendor questionnaires, quality agreements, and technical documents. Assess vendor certifications (e.g., GMP, ISO), audit reports, and regulatory approvals. Verify supplier COAs and related test data. Vendor Audits: Plan, schedule, and conduct on-site and remote audits of vendors (with QA audit team). Prepare audit plans, checklists, and audit reports. Follow up on audit observations and ensure timely CAPA implementation. Risk Assessment: Perform risk assessments of vendors based on quality performance, audit results, and regulatory history. Categorize vendors as Approved, Conditional, or rejected based on risk rating. Performance Monitoring: Monitor ongoing vendor performance via complaint trends, deviations, OOS, and OOT data. Maintain vendor performance scorecards. Lead periodic review meetings to evaluate vendor quality performance. Quality Agreements: Draft, review, and manage quality agreements with vendors. Ensure roles and responsibilities related to quality are clearly defined. Change Control & Deviation Handling: Evaluate and manage vendor-related change control proposals. Handle deviations related to material supply and vendor performance. Show more Show less