Production Executive (Biotech API)

Roles and Responsibilities

1. Maintaining all equipment/machines in consultation with maintenance department.

2. Maintaining flow of material as per man & material movements.

3. Maintaining availabilities of spares / change parts required for equipment/machines located in the

department in consultation with Maintenance department.

4. Responsible for operation, cleaning of STR and wave bioreactor & operation and cleaning of chromatography system and related equipment.

5. Responsible for calibration of instruments & maintenance of status label of instruments, equipment and area.

6. Monitoring of area cleaning and maintenance as per cGMP requirements.

7. Responsible to fulfill the operational requirements of area as per cGMP requirements.

8. Issue & receipt of raw materials from stores required for batch operation as per BMR process.

9. Responsible for proper gowning & change as per relevant SOP.

10. Maintaining flow of material as per man & material movements.

11. Execution of batches as per BMR.

12. Filling of logs and BMR & other cGMP documents as per requirement.

13. Reviewing SOPS of all activities of the line.

14. Responsible to perform pre-operational checks and line clearance from Q.A. prior to each operation.

15. Reporting any abnormal observation to superior during operation.

16. Responsible for various water rinse samples of cleaned equipment as per requirement.

17. To understand and follow the company's environment health and safety policy.

18. To follow Safety Rules and Standard Operating Procedures at the workplace.

19. Participate in environment, health and safety training and awareness programmes.

20. To understand SOP of relevant machinery, tools, substances, etc. before use.

21. Use of essential Personal Protective Equipment at workplace.

22. Report any abnormalities, near miss incident, unsafe act & conditions in the workplace, equipment, etc. which might endanger environment, health and safety to respective departmental EHS coordinator or EHS department.