Production Officer/ Sr. Officer

1. To follow the written procedures for execution of batch activity in injection / Ointment department.

2. To participate in in-house training as arranged by the company.

3. To responsible for the safety norms while performing the activity.

4. To carry out the batch manufacturing activity as per product BMR and take participation in Aseptic process simulation activity.

5. To responsible for that the machine are producing quality product by periodic checks on output and fulfill the requirements of companys objectives with quality procedure.

6. Co-ordinate with the other department like maintenances, QC, QA, Micro warehouse, packing staffs for day to day activities.

7. To responsible for complete the online logbooks, BMR day to day basis.

8. To carry the plant preventive maintenances activity of all equipments and machineries as per schedule with maintenances department.

9. To ensure the validation /calibration status of equipment, machine, and instruments before start the batch activities.

10. To follow the cGMP procedure as per defined in SOP.

11. Maintain area and machine neat and clean as per frequency defined.

12. To take the process printouts from machine and attach to the respective BMR’s with signed.

13. To responsible for vials, ampoules, Eye drop bottles and Ointment quantity, Lot No., Batch No., product name etc against issue slip before taking for Decartoning and washing.

14. Carry out operation and cleaning of vial washing machine, Tunnel, Bung processer, Autoclave, Terminal Autoclave, External washing machine, Garment washing and drying machine with operator.

15. To ensure that the cleaning and drying of filters after completion of activity.

16. Report any non conformity to Production Manager.

17. To carry out the Operation of Bubble point test apparatus to ensure the integrity of filters.

18. To carry out the sterile filtration of Bulk Solutions.

19. To verify the quantity of raw material before start batch manufacturing.

20. To carry out the Batch manufacturing procedure as per procedure mentioned in BMR.

21. Carry out machine part assembling of Vial Filling machine, Ampoule filling machine and Eye/Ear drop machine.

22. Carry out Vial Loading unloading activity with ALUS.

23. To ensure the CIP/SIP Status of Lyophiliser before loading of batch.

24. To carry out the operation and cleaning of machine, LAF, Mobile LAF, Online Particle counter, Portable Particle counter.

25. Carry out any other task and assignment as deemed appropriate by Production Manager.

26. To responsible for carry out preventive maintenances of machine and reduce downtime /breakdown of machine.

27. To responsible for online record monitoring/analysis of machineries and areas.

28. To be responsible to shift any new location as desired by the Management.

29. Accountable for elimination of the data integrity events and implementation of the SOP and policy.

30. Responsible for monitoring and assessing hazardous and unsafe situations and developing measures to assure personal safety.

31. Responsible to promote safety in premises.