Role & responsibilities

1. Follow the instruction & procedure given in Entry- Exit SOP (Standard Operating Procedure) of Grade C, decartoning area and Grade B area.

2. Responsible a procedure for proper functioning or behaviour in aseptic area.

3. Follow the personnel hygiene practices in factory premises.

4. Follow the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per given in SOP.

5. Responsible for monitoring of temperature, relative humidity and differential pressure.

6. Responsible for monitoring of differential pressure of laminar air flow units and pass boxes.

7. Responsible for handling of material movement in production area.

8. Responsible for maintain the document as per GDP and area as per cGMP.

9. Responsible for to maintain day to day records.

10. Responsible for training to new joining chemist, workers and operators for their respective job.

11. Carrying out the line clearance before starting the operation.

12. Responsible for planning of manufacturing as per availability of RM and PM.

13. Responsible for supervision of preparation and filtration of cleaning/ disinfectant solutions and fogging solutions.

14. Responsible for supervision of equipments/ machines and utility readyness before batch manufacturing.

15.Responsible for supervision of operation and cleaning of steam sterilizer, compounding vessel and holding vessel, vial washing machine, sterilization and depyrogenation tunnel, washing and drying and wrapping of garments and pass box and laminar air flow.

16. Responsible for supervision of handling of filters, filter integrity testing apparatus, silicon tubing, decartoning area and hose pipes and cleaning and wrapping of glassware, auxiliary items and machine parts.

17. Responsible for supervision of operation of pH meter and stirrer.

18. Responsible for supervision of aseptic process stimulation, post media fill cleaning and sanitization of machine and area as per procedure.

19. Responsible for destruction of media filled vials.

20. Responsible for supervision for general area cleaning and sanitization of grade C and D area and fogging activity of respective area.

21. Responsible for verification of load cell.

22. Responsible for verifying the handling of waste generated in production area.

23. Responsible for non viable particle count (online and offline) monitoring.

24. Recording the operation and cleaning details in batch manufacturing record and equipment uses log book.

25. Responsible for handling of equipment like homogenizer, rota evaporator, magnetic stirrer, ultrsonicator, pH meter and fogger.

26. Follow the procedure for dispensing room and responsible for RM and PPM dispensing and additional materials issuance.

27. Responsible for all data entry for batch manufacturing process in pharmacloud system.

28. Responsible for audit preparation and execution.

29.To undergo periodic medical checkup arranged by the company.

30.Performing the task assigned by the supervisor.

31. Reporting regarding unsafe act/ unsafe condition/ accident/ incident to supervisors.

Production Officer/ Sr. Officer/Executive (Injectable Only)