Senior Officer

1

Responsible for the Handling of market complaint at site.

2

Responsible for the Handling of Deviation management at site.

3

Responsible for the Handling of CAPA and Global CAPA management and effectiveness checking at site.

4

Responsible to co-ordinate the execution of mock recall and market recall.

5

Responsible to review and tracking of Audit Responses.

6

Responsible to raise, review and tracking of Quality Alert.

7

Responsible to ensure timely closure of QMS documents.

8

To perform activity as per authorization in EDMS, LMS and TRACKWISE software.

9

Responsible for performing IPQA activities.

10

To perform process validation and cleaning validation sampling activity in shop floor.

11

To review new/exhibit/transfer and executed master BMR’s and BPR’s.

12

To review batch records and associate annexures, checklists etc.

13

To perform Product/Recipe approval, SFG/FG release, sampling, sample posting etc. in SAP HANA systems

14

To prepare and execute hold time study protocol and perform sampling activity.

15

To prepare and review process validation protocol and report.

16

Preparation and Review of Annual product quality review.