Essential Job Functions:

 

1.  Implement Operate, Monitor and Maintain Quality Management Systems which enable operations on site to occur in an efficient manner and compliance with global quality standard and c GMPs.

2.  Evaluate and approve of Change controls, Deviations, Complaints, Out of specifications, Out  of  trends,  CAPAs,  Internal  audit  findings,  External  audit  findings  and  propose corrective and preventive actions.

3.  Assist to provide training on quality system procedures and general GMP training.

4.   Participate /perform the internal audits as planned schedule.

5.  Assist in scheduling and management of management review meeting.

6.   Organize   the   CAPA.  meeting,  Coordinate/Manage  CAPA  efforts  and  interact  with customers  to  conduct  complaint  investigations.  Assign  responsible  person  for  CAPA owner in Track-wise system.

7.  Assist to author, change and update quality procedure as applicable.

8.   Ensure the timely approval of the Process validation protocol and reports.

9.  Coordinate  and  facilitate  the  review  of  documents  required  for  the  manufacturing activities.

10. Management and approval of investigations.

11. Approval of all types of protocols and reports.

12. Provide support in Artwork Management System.

13. Ensure the timely approval of batch production records.

14. Review and approval of annual product quality review/ management of retention sample.

15. Responsible for Mock recall/Recall and withdrawal of Drug Products.