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.
6 To prepare compliance report for internal / external audit and Compliance of internal/external audit points.
7 To Initiation, investigation and evaluation of Change control, CAPA and deviation.
8 To prepare review SOPs.
9 To initiate, investigate, lock and closing of TCC, CC, Deviation and Incident report and verify the implemented CAPA and its effectiveness.
10 To Prepare PQR/APR.
11 Investigation and report preparation of Market Complaints and product failures at shop floor.
12 Online review of GMP documents.