Executive, Quality Assurance-Quality Management System (QMS)

As a Vendor Quality Assurance Specialist, your role is crucial in ensuring that all vendors supplying materials meet the company's quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities: - Initiate and coordinate vendor qualification activities for both new and existing vendors. - Prepare and maintain vendor qualification dossiers and files to ensure documentation accuracy. - Coordinate with procurement and other departments to gather necessary vendor data and documentation efficiently. - Ensure vendors comply with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to uphold product quality. - Review and evaluate vendor questionnaires, quality agreements, and technical documents for compliance. - Assess vendor certifications such as GMP and ISO, audit reports, and regulatory approvals to verify vendor credibility. - Verify supplier Certificates of Analysis (COAs) and related test data to maintain quality control standards. - Plan, schedule, and conduct on-site and remote audits of vendors in collaboration with the Quality Assurance (QA) audit team. - Prepare audit plans, checklists, and reports to ensure thorough evaluation of vendor performance. - Follow up on audit observations and ensure timely Corrective and Preventive Actions (CAPA) implementation for continuous improvement. - Perform risk assessments of vendors based on quality performance, audit outcomes, and regulatory history to mitigate potential risks. - Categorize vendors as Approved, Conditional, or rejected based on risk rating to maintain quality standards. - Monitor ongoing vendor performance through complaint trends, deviations, Out of Specification (OOS), and Out of Trend (OOT) data analysis. - Maintain vendor performance scorecards to track and evaluate vendor quality performance effectively. - Lead periodic review meetings to assess and enhance vendor quality performance consistently. - Draft, review, and manage quality agreements with vendors to establish clear roles and responsibilities related to quality assurance. - Evaluate and manage vendor-related change control proposals effectively to ensure minimal disruption to the supply chain. - Handle deviations related to material supply and vendor performance promptly to maintain product quality. Qualifications Required: - Bachelor's degree in a relevant field such as Quality Assurance, Supply Chain Management, or related discipline. - Proven experience in vendor qualification, quality assurance, and supplier management within a regulated industry. - Strong understanding of Good Manufacturing Practices (GMP), regulatory requirements, and quality standards. - Excellent communication, organization, and problem-solving skills to effectively interact with vendors and internal stakeholders. - Ability to work independently and collaboratively in a dynamic environment to ensure vendor quality compliance. - Certification in quality management systems or auditing (e.g., ISO 9001, ASQ Certified Quality Auditor) is a plus. (Note: Additional details about the company were not provided in the job description),