Quality Assurance Officer -Reputed Medical Device Industry -Chennai, Tamil Nadu, India -4LPA -Pooja

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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