รายละเอียดงานKey Responsibilities:
1. Develop, maintain, and continuously improve the Quality Management System (QMS) in compliance with GMP, RBA, ISO 9001, customer requirements, and company standards.
2. Prepare, review, update, and control quality documents, including Quality Manual, SOPs, Work Instructions (WI), Forms, and Records.
3. Ensure effective document control, record management, and compliance across all departments.
4. Plan and conduct Internal Audits, coordinate customer and certification audits, and follow up on corrective actions.
5. Manage Corrective and Preventive Actions (CAPA), perform Root Cause Analysis, and verify the effectiveness of corrective actions.
6. Support GMP, RBA, and quality compliance activities, including audit preparation and employee training.
7. Conduct risk assessments and support Continuous Improvement (Kaizen) initiatives.
8. Coordinate with cross-functional teams, including Production, Engineering, Warehouse, Purchasing, and HR, to ensure quality system compliance.