JOB DETAILS

1) Review & preparation of MES & other GMP Software Qualification Documents.
2) Preparation of URS, GxP Risk Assessment, Qualification protocols (OQ, PQ), RTM, VSR.

3) Review URS, RA, Design documents, qualification document.

4) Handling of post implementation changes documents.

5) Execute OQ and PQ.
QMS (Investigation and report preparation):

1) To prepare compliance report for internal / external audit and Compliance of internal/external audit points.

2) To Initiation, investigation and evaluation of Change control, CAPA and deviation.

3) To prepare & review SOPs.

4) To initiate, investigate, lock and closing of TCC, CC, Deviation and Incident report and verify the implemented CAPA and its effectiveness. 

5) To Prepare PQR/APR.

6) Investigation and report preparation of Market Complaints and product failures at shop floor.

7) Online review of GMP documents.<...