หน้าที่ความรับผิดชอบ

• Oversee and manage all QA activities in compliance with GMP, PIC/S, and other pharmaceutical regulatory standards.
• Develop, implement, and maintain QA systems and quality improvement initiatives.
• Lead internal and external audits, ensuring readiness and compliance at all times.
• Collaborate with cross-functional teams including Production, QC, and Regulatory Affairs to ensure product quality.
• Conduct root cause analyses and implement corrective and preventive actions (CAPA).
• Train and mentor QA staff, promoting a culture of quality throughout the organization.
• Prepare and manage QA documentation, including SOPs, batch records, and deviation reports.
• Continuously monitor regulatory updates and ensure the organization stays compliant.