หน้าที่ความรับผิดชอบ

• Support in implementation and maintenance of quality management system policies and procedures and ensure compliance with relevant international standards and regulatory requirements.
• Manage the documents life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
• Ensure integrity of all QA files for the purpose of efficient and timely retrieval of generated documents.
• Assist in internal and external audit and inspections.
• Manage post-market surveillance activities such as change control, NC, CAPA, complaint, adverse events, PV activities and take actions if necessary, to support closure of issues.
• Quality document review for support the import product shipment/clearance in terms of Certificate of Analysis/GMP Certificate/ISO Certificate for product release and ensure compliance with Regulation rules