หน้าที่ความรับผิดชอบ

• Provide the AMV protocol with the OLIC template follow the master test method and specification from the client.
• Conduct the analytical method verification and validation follow the AMV protocol and supportive document from the client.
•  Provides database support, generate protocols/reports and analyze process data.
• Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
• Assist in preparing for and participating in FDA audits, customer audits, etc.
• Other tasks and responsibilities as appropriate or required.