Filling Operator

Role & responsibilities

1. Follow the gowning procedure and personal hygiene as per SOP.

2. Should have exposure to operate, Blow Fill Seal, Ampoule Filling Machine, Vial Filling Machine and awareness about isolator

3. Ensure that the settle plates exposure and NVPC data shall be within limits before starting of filling machine assembly.

4. Responsible for line clearance of the filling area and filling machine, no abnormalities or deviations shall observe during the line clearance process.

5. Ensure all utilities shall be available prior to start of the batch filling

6. Verify the environmental conditions (temperature and pressure) of the filling area, it should be within limits before starting the filling machine assembly.

7. Affix the proper status labeling on materials, areas, and equipment.

8. Follow aseptic behaviour as per SOP.

9. Run and operate filling machines and other equipment in a production environment.

10. Attend the filling interventions as per SOP and sanitize hands after each intervention.

11. Perform pre- and post-integrity testing of product filters according to the BMR and SOP.

12. Carry out daily area cleaning using the scheduled disinfectant.

13. Ensure the production line operation efficiently.

14. Perform the filling in-process checks as per BPCR.

15. Ensure the timely submission of filled logbooks and other Good Manufacturing Practice (GMP) documents to quality assurance.

16. Maintain a safe and clean work environment.

17. Operate and monitor production equipment, tools, and machines following standard operating procedures.

18. Set up different production lines for various products or batches simultaneously.

19. Maintain spare parts and changeover parts with proper cleaning and status labelling.

20. Adjust machine settings to maintain maximum production output without compromise the finish product quality.

21. Support installation, validation, calibration, and qualification activities for filling machines.

22. Follow production schedules and work orders to achieve daily objectives.

23. Clean the work area according to safety and hygiene standards.

24. Monitor equipment faults and report major breakdown to maintenance departments.

25. Record production data, output quantities, quality control results, and equipment performance. 23. Collaborate with colleagues to ensure smooth workflow and achieve required production.

26. Do not leave the area until the reliever arrives in the filling area

27. Possess computer application skills to enter and interface with equipment.

28. Understand production processes and workflow.

29. Follow all safety measures, Carry out cleaning, lubricating, and general maintenance of equipment and machines.

30. Assist in training new operators in machinery operation and safety procedures.

31. Participate in team meetings and contribute suggestions for process improvements.

32. Monitor the consumable inventory and inform to supervisors of any shortages.

33. Check product quality at several stages in the process.

34. Operate filling machine and other equipment efficiently within the production environment.

35. Follow standard operating procedures (SOPs) for all activities

36. Maintain proper communication with supervisors and coworkers regarding ongoing productions and issues.

37. Participate in emergency response procedures and safety drills.

38. Assist in introducing new production processes or technologies into service.

39. Observe and report any potential quality concerns or safety hazards to supervisors.

**OTHERS:**

- Ensure compliance with Environmental Health and Safety (EHS) norms at all times.

- Maintain compliance with cGMP (Current Good Manufacturing Practices) in all operations.

- Follow ALCOA+ principles.

- Uphold the highest level of data integrity consistently.

- Immediately escalate any abnormalities observed to the immediate supervisor or HR department.