หน้าที่ความรับผิดชอบ

• Take QC Role in a new project of facility/equipment/process and support team which is related to quality control function
• Prepare documentation of Quality Control as GMP required (e.g. Specification, Test Procedure, Stability Protocol, Standard Operating Procedure, Test Report, Certificate of Analysis)
• Responsible for quality control and approval of incoming raw material and packaging material for manufacturing process
• Perform physical/chemical/microbiological testing for intermediate/finished product as per material specifications
• Organize product stability testing and maintain stability report for quality review and regulatory audit
• Arrange and manage laboratory equipment/ laboratory inventory to ensure suitability and efficiency of application
• Participate in Method Transfer of new product analytical procedure (as required) to ensure the reliability of testing result – transfer method from R&D Department
• Support a group of validation team in the area of laboratory testing for all validation activities
• Support Quality Management System to monitoring product quality and ensuring strictly compliance with GMP regulation and other relevant Quality Guidelines such as ICH.