หน้าที่ความรับผิดชอบ

1. MAJOR TASKS:

   1. Responsible for quality control of new projects, including raw materials and finished products, as assign to meet target.
   2. Organize physical testing and chemical testing for raw materials as per material specifications within scheduled time.
   3. Organize method validation testing and supporting documents of new projects within scheduled time and meet requirement.
   4. Organize product stability testing and supporting documents of new projects within scheduled time and meet requirement.
   5. Enforces company policies: GMP, GLP, Safety and personnel discipline

DUTIES & RESPONSIBILITIES:

1. Responsible in physical and chemical testing on raw material of relevant projects and the development of the testing method of new raw materials as per specification. Prepare testing monograph and other supporting documents. Verification analysis report/worksheet
2. Responsible in the development of the analytical method of new finished products such as physical testing and chemical testing. Prepare the new testing method/specification to meet requirement, and verification analysis report/worksheet.
3. Organize raw material control in SAP system to meet requirement within specified target date.
4. Prepare the new testing method, master calculation files and prepare standard man-hour, request column and reagent for new testing method and trial any trial assay on new products procedure.
5. Assigns testing schedule to analyst within prescribed lead time or specified target date.
6. Perform analytical method validation protocol, assigns analytical method validation testing to analyst and conclusion to meet target.
7. Perform stability testing protocol, estimate the quantity of the stability sample used, planning and assigns stability testing to analyst to complete within schedule and investigation for out of specification and trend of analysis, and prepare stability reports conclusion for submission.
8. Directly supervises technician, glassware washer and helps in solving problems of analysts in chemical Lab.
9. Conducts training and enforces company policies particularly the policy on personnel discipline, GMP, GLP and safety.
10. Responsible for supervise HPLC testing such as: apparatus maintenance, HPLC column, back  up data and maintain all relevant records.

11. Maintains preventive maintenance and Calibration of equipment within due date.