Batch Preparation Operator

Role & responsibilities

. Follow the gowning procedure and maintain general hygiene in the component/compounding preparation area.

2. Affix the proper status labeling on materials, areas, and equipment. Manage the transfer of raw materials from the warehouse to the compounding area.

3. Responsible for line clearance of the batch preparation area, no abnormalities or deviations shall observe during the line clearance process.

4. Verify the raw materials prior to use and ensure it should meet as per requirements.

5. Participate in the installation, commissioning, and qualification of equipment, vessels, and other accessories.

6. Perform cleaning, steaming, CIP (Clean in Place), SIP (Sterilization in Place), and PHT (Pressure Hold test) of mixing vessels, holding vessels.

7. Operate and monitor process vessels, equipment, and machines following standard operating procedures (SOPs).

8. Prepare autoclave loads according to established load patterns.

9. Conduct daily autoclave operations for leak tests, Bowidic, and other regular loads such as garments/filtration, filling, and disinfectant.

10. Execute batch manufacturing activities and record these activities online in the batch manufacturing record.

11. Carry out daily, weekly, and monthly calibrations of weighing balances, pH meters, DO meters, and head space oxygen analyzers in compliance with SOPs.

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

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

14. Prepare and filter disinfectant solutions required for APA (Aseptic Processing Area) and Non-APA cleaning.

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

16. Ensure the availability of BMR in the batch preparation area prior to start of the batch manufacturing

17. Ensure the all utilities shall be available prior to start of the batch manufacturing

18. Adhere to production schedules and work orders to meet daily objectives.

19. Monitor equipment faults and report major issues to maintenance personnel, if required.

20. Record production data, including input quantities and quality control results.

21. Collaborate with colleagues to ensure a smooth workflow and achieve production targets.

22. Conduct periodic aseptic media fill validations and periodic qualification of equipment as per the schedule.

23. Utilize computer applications to enter and interact with equipment data.

24. Demonstrate knowledge of production processes and workflow.

25. Read and understand technical documents and work orders.

26. Adhere to all safety measures and wear appropriate personal protective equipment (PPE) at all times.

27. Assist in training new operators on machinery operation and safety procedures.

28. Actively participate in team meetings and contribute suggestions for process improvements. 25. Monitor the consumable inventory and inform to supervisors of any shortages.

29. Follow standard operating procedures (SOPs) for all assigned tasks by the production supervisor.

30. Operate machinery and equipment efficiently within a production environment.

31. Maintain the work area accordance with safety and hygiene standards.

32. Ensure proper communication with supervisors and co-workers about ongoing production matters.

33. Conduct a proper shift handover before leaving the production area.

34. Participate in emergency response procedures and safety drills.

35. 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.