QA Officer -Reputed Medical Device Industry -Delhi, NCR, India -3LPA -Kajal

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.
FUNCTIONAL AREA
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