1. Overseeing the maintenance and renewal of licenses (Manufacturer, GMP, servicing vendor contract and etc.)
2. Ensure the requirements of Good Manufacturing Practice (GMP) and proper Standard Operating Procedures (SOP) are established, developed, periodic review, revision, implemented and maintained accordingly
3. Manage of the Document Management System be a custodian of the quality documents (e.g. Site Master File, Documented Procedures, etc), keep records and filing in proper order
4. To approve specifications, sampling instructions, test methods and other Quality Control procedures
5. To ensure the required initial and continuing training for manufacturing personnel is carried out and adapted according to need. Manage of the GMP Training System, schedule, teach, certify and monitor
6. Ensure warehouse storage and cleanroom stations cleanliness and environmental conditions are monitored and properly upkeep
7. Review scrutinize and approval of the test and/or inspection results on incoming receipt starting and packaging materials, excipients, intermediate, bulk and finished goods in a timely manner
8. Oversees and conduct sampling inspection, retention and in-house testing
9. Ensure manufacturing operation is within In-Process Quality Control (IPQC)
10. To monitor and ensure all necessary testing is carried out and the associated records evaluated, release or reject of finished goods in a timely manner
11. Batch Manufacturing Record (BMR) review and release
12. To ensure the qualification and maintenance of testing instrument, premises and equipment (laboratory instrument and production equipment maintenance, UV light, lighting and safety features like exit emergency light functionality, fire extinguisher validity and etc.)
13. Examination and assessment on the hygiene process and the production as per the company regulations
14. Conduct and assess new supplier factory qualification, continuing existing supplier factory assessment
15. To assess and monitor the outsource contractors (accredited laboratories, pest controllers, contracted manufacturers and etc.)
16. Review updates by local governing authorities (HSA) or PIC/S published latest revision, promulgate and implement new quality procedures when deem necessary
17. Manage of the Internal Audit System, schedule and conduct internal audit at planned interval based on the status and importance of the activity. The audit shall be conducted in accordance with procedures
18. To ensure that the appropriate validations (cleaning, equipment and processes) are carried out; manage validation through design, run, test and upgrade systems and processes through assessing measurements and interpretation of data
19. Manage of the annual Product Quality Review and stability process
20. Manage of deviations, complaints, incidents and recalls with proper handling, following up and investigation
21. Manage of the Corrective and Preventive Action System. Formulate the corrective measures for product defect or non-conforming product through the analysis of the causes and approach
22. Oversees quarantine stock and disposition
23. Manage of the Continual Improvement System, ensure suitability and effectiveness of the GMP is carried out at all times, strategize plans to enhance process to meet the quality of the products to build up quality reputation and the company brand name
24. Manage of the Risk Management process
25. Acting as primary quality contact and qualified person for internal and external quality compliance matters
