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JOB ROLES AND EXPECTATIONS:

Key Result Area

Key Roles / Duties

Supervision

1. To conduct environmental monitoring of the clean room and inform the maintenance department in case of any deviations.
2. To supervise cleaning and disinfection of the clean room as per the SOP.
3. Report any maintenance work in the clean room to the maintenance department.
4. To ensure availability of a sufficient number of garments in the clean room.
5. To do routine checks on the cleanliness of workers inside the clean room area.
6. To ensure that all clean room staff adhere to proper gowning procedures of the clean room as per SOP.
7. To supervise monitor the standards of hygiene and cleanliness in the dispensing area all the time.
8. Check inventory levels of materials required. That is cleaning agents, gloves etc.
9. To ensure that SOPs are followed in the process flow of water treatment.
10. To enforce cGMP guidelines and ensure their implementation in the water treatment plant.

Process control

1. To fill out the BMR requisition upon receipt of the production plan and send it to QA department for BMR registration.
2. To get BMR approved wit authorized signatures.
3. To take store requisition slips from the BMR and get authorized signatures.
4. To make the required equipment available in advance which is necessary for dispensing like sterilized scoops, double plastic bags and cable ties.
5. To give proper identification tags on issued material in the dispensing area.
6. To weigh and issue correct quantity of raw materials and balance calibration in the dispensing area.
7. To monitor positive pressure and temperature/humidity of the dispensing area and inform engineering department if any abnormality is found.
8. To check the cleaning of dispensing booths, scoops after the dispensing process.
9. To return excess raw and packaging material after completion of dispensing to the store using a return slip.
10. To receive plastic granules for daily manufacturing activities and be accountable for them.
11. Checking and filling of batches online for proper production planning and accountability.
12. To transfer dispensed raw materials to the mixing area, pass box for batch manufacturing.
13. To ensure that batches are manufactured on time as per the SOP.
14. To ensure that CIP/SIP processes are undertaken as per validated procedures.
15. To do filter intensity tests on both air and product filters as the SOP.
16. To start and stop production filling lines.
17. To ensure smooth functioning of the water treatment plant.
18. To liaise with the team leader in case of any maintenance works.
19. To ensure constant and even supply of quality RO water and WFI to all points of usage.
20. To ensure that all equipment undergo routine validation and calibration processes.

Documentation

1. To do online documentation.
2. To ensure that all BMR records are properly filled on line.

Any other Duties

1. Ensure that any other duty assigned by HOD is executed to Management expectations.

AUTHORITIES:

• Operate water treatment plant equipment.
• Perform chemical cleaning of the plant and maintain it in good working conditions.
• To weigh and issue the correct quantity of materials to clean room and do balance calibration in the dispensing area.
• Do raw material requisitions from the stores and give accountability for them.
• Manufacturing of product batches.
• Verification of cleanliness of the clean room and proper gowning of cleanroom personnel.
• Monitoring of the manufacturing process.