หน้าที่ความรับผิดชอบ

1. 1. Follow up Include individual validation plan of the following but not limited to:-

• Process (GMP) validation
• Process (Product) validation
• Facilities validation
• Cleaning validation
• System, Utility and Equipment Qualification
• Analytical method validation
• Computerized system validation

2. Follow up with concerned department to perform all validation according to the set up

validation master plan.

3. Follow up equipment qualification of new equipment and major change of existing

equipment.

1. Establish cleaning validation protocol and conclusion of critical manufacturing equipment.
2. Follow up facility validation of new facility and major change of existing facility.
3. Follow up validation document from concerned department.
4. Keep and control validation document.
5. Prepare and update concerned document: work instruction, Quality procedure, etc.
6. Co-ordinate for validation activities of new manufacturing equipment, system, utility and facility project to guide and conduct validation & qualification plan.
7. Follow up and report the environmental monitoring program is state and effectively carried out (water, air, personal hygiene) as per the plan.
8. DOCUMENTATION
9. Prepare validation document, work instructions, validation procedure and related documents.
10. Prepare validation master plan.
11. Review validation protocols, validation report, calibration reports.
12. MANAGEMENT
13. Develops and implement validation training program.
14. Ensures that the validation systems cost effective.
15. Enforces company polices on CGMP discipline and safety.