Officer

Job description

1. Monitoring of gowning and sanitation practices in area of operation.
2. Monitoring of compliance of standard operation procedure in production & packaging department.
3. Reporting the noncompliance of written SOP of machine operation.
4. Line clearance inspection and clearance of cleaned area, Equipment on compliance with checklist, reporting of noncompliance to area supervisor and QA Executive.
5. In process testing-sampling and performing in process test of Running Batch in area of Supervisions per defined frequency.
6. Sampling-performing sampling of blend/Bulk, in process validation/stability samples and finished good as per standard operating procedure and submitting sample to concerned lab instantly. Maintain sample receipt log for the same.
7. Reporting shift activity in log as per SOP.
8. Verifying critical process parameter as defined in Batch Process record (MI & PI).
9. Reporting deviation process breakdown in shift report.
10. Verifying stage wise yield.
11. Verifying on time entries by Production workmen & Staff.
12. Reporting any abnormal environmental condition Temperature % RH, differential pressure difference to shift supervisor for rectification, if problem persists initiating deviation.
13. Completing the training assigned as per the training need identified by participating in trainings organized or self-reading.
14. Investigating reported market complaint, deviation OOS.
15. Following all regulations of cGMPs as per schedule M.
16. To support the internal audit/Regulatory/FDA audit with best of practices.
17. To operate the analytical equipments in Q.C. as per the allotted work in the shift.
18. To calibrate the analytical equipments as per the calibration procedure for assigned responsibility of calibration.
19. To follow the procedure of good documentation and recording of result as per SOP on GDP and good execution of laboratories practices.
20. To report the observations of analysis on analytical equipments promptly in respective BPR S.
21. To maintain the analytical equipments and laboratories in good state of operation.
22. To maintain the safety procedure in handling analytical equipment and hazards.
23. Completing Batch Process record entries in shift.
24. Following all standard operating procedure applied to IPQA & Plant Procedure