Head Of Qa And Qualified Person
CurrentHead of QA Responsibilities:▪ QMS Oversight: Develop, implement, and maintain Quality Management System for compliance.▪ Regulatory Compliance: Ensure operations meet regulations and standards (GMP, ISO).▪ Audit Management: Conduct internal audits and manage external audit processes.▪ Process Improvement: Lead initiatives to enhance quality and efficiency.▪ Team Leadership: Manage and mentor QA team.▪ Risk Management: Identify and mitigate product quality risks.▪ Supplier Quality: Oversee supplier qualification and performance.▪ Deviation Management: Investigate deviations and implement CAPAs.▪ Document Control: Maintain quality documentation.▪ Quality Reviews: Conduct reviews with cross-functional teams.▪ Client Communication: Handle client complaints and quality topics.▪ Computerized Systems: Manage and validate systems for regulatory compliance.Qualified Person's Responsibilities in QC Lab:▪ Compliance Verification: Ensure lab adherence to GMP guidelines.▪ Storage Monitoring: Verify proper storage conditions.▪ Documentation Compliance: Ensure processes/results meet documentation standards.▪ Certificate Approval: Approve Certificates of Conformity for products.
