Overview

• Salary

  60,000 THB ~ 70,000 THB

• Industry

  Trading(Pharmaceutical/Medical Equipment), Manufacturing(Pharmaceutical/Medical Equipment)

• Job Description

  DUTIES & RESPONSIBILITIES:
  
  1. Manage the daily activities and work schedules of the product testing based on production programs and delivery requirement.
  2. Provide of finished products test method.
  3. Provide trend analysis of testing results of product.
  4. Review and decision marking of all results in analysis worksheet to ensure the result are in trend for analysis.
  5. Review Analytical Method Validation protocol/conclusion.
  6. Coordinate the third party for proficiency testing, Interlaboratory comparison.
  7. Review results of Interlaboratory comparison and conclusion.
  8. Prepare/update subcontract testing list and approve service contractors list.
  9. Prepare of finished product specification, master certificate of analysis and analysis report, request of reference standards/reagents and helping in any trial assay if necessary.
  10. Organize and follows up the calibration program of testing equipment.
  11. Review of stability protocol, organizes the stability testing schedule program starting from samples collection, monthly testing schedules and stability test report preparation in timely manner.
  12. Prepare QC document to support Regulatory Affairs Department for drug registration and variation submission.
  13. Key actual man-hour in SAP system to support Finance and Accounting Department.
  14. Supervise the updating of references standard list and reagent list and maintain of their inventory and the proper storage.
  15. Provide qualification of laboratory equipments and contacts maintenance services when they go out of order.
  16. Maintain the laboratory documents for the specified time and the subsequent disposition thereafter.
  17. Enforce company policies particularly the policy on discipline for GMP & GLP and safety.
  18. Perform function in the absence of QC Department Manager in quality control concern.
  19. Maintain quality control area and equipment for cleanliness to prevent cross contaminates.
  20. Provide relevant SOP and specification concerning quality control and their updates.
  21. Furnish the analysis man-hours and lead time for products manufactured assayed when requested.
  22. Recommend hiring, suspension and dismissal of personnel under supervision.
  23. Monitor the efficiency of analysis performance and lead time improvement.
  24. Perform other job that is assigned by Quality Control Department Manager.