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MAJOR TASKS:

1. Responsible for quality control of new products, including analytical method development, raw material release, and finished product control to meet target timeline as company requirement.
2. Responsible for Analytical method validation and stability study of new products, existing products, material including cost evaluation.
3. Responsible for ACTD document preparation for new products, variation or registration renewal for submission to FDA as regulation as target timeline.
4. Management resources, including human resources and Lab instrument capacity for supporting new products for achieved timeline target.
5. Enforces company policies: GMP, GLP, ISO9001, ISO/IEC17025 Safety and personnel discipline.

DUTIES & RESPONSIBILITIES:

1. Manage developing or improving of analytical method for new products or existing products.
2. Provide analytical monograph and specification for both raw material and finished product.
3. Provide analytical method validation report and stability study report including cost evaluation.
4. Provide required documents and accompany revising to support new product registration.
5. Provide and arrange resources to handle all requests for analytical development.
6. Provide procedure of operation to ensure systematical control.
7. Improve efficiency of all resources.
8. Coordinate with the Principal or third party lab for proficiency testing/interlaboratory comparison.
9. Prepare/quality subcontract testing lab and service contractors in new testing/service.
10. Prepare finished product specification, master certificate of analysis and analysis report.
11. Review stability protocol and follow up stability test schedule to complete in timely manner.
12. Authorized AD Section Manager can approved test report or certificate of analysis in the absence of QC Department Manager.
13. Supervise the updating of references standard list and reagent list and maintain of their inventory and proper storage.
14. Provide qualification of laboratory equipments and contacts maintenance services when they go out of order.
15. Arrange the supply of laboratory materials and control the inventory, cost of consumable materials and the annual usage.
16. Maintain the laboratory documents for the specified time and the subsequent disposition thereafter.
17. Perform function in the absence of QC Department Manager in quality control concern.
18. Provide relevant SOP and specification concerning quality control and their updates.
19. Prepare the analysis man-hours and lead-time for products/material under responsibility.
20. Recommend hiring, suspension and dismissal of personnel under supervision.
21. Monitor the efficiency of analysis performance lead time improvement.
22. Perform jobs that are assigned by Quality Control Department Manager.