Aseptic Manufacturing

About the Company

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.

Educational Qualifications:

• Required: B. Pharm (Bachelor of Pharmacy) or Diploma in Pharmacy.
• Experience: 3-7 Years
• Key Skills- Aseptic, Filling, Autoclave, Lyophilization

Primary Responsibilities

1.Follow cGMP in production department and online documentation.

2. Follow entry/ exit procedure as per SOP.

3. Monitoring and recording of area temperature and differential pressure in the records.

4. Monitoring and recording of UV lamp hours in the garment cubicles, LAF readings in the records.

5. Follow Aseptic practices and Behaviors in Aseptic Area.

6. Performing filtration of the formulated solutions for filling.

7. Carryout integrity testing of Capsule Filter as per SOP.

8. Performing Vial/Cartridge filling machine assembly and aseptic connection as per SOP.

9. Performing changeover of machine parts with respect to batches.

10. Loading/Unloading of vials in & from lyophilizer.

11. Unloading of sterilized articles from the autoclave as per SOP.

12. To participate in Aseptic Process Simulation or Media Fill Study/ Gowning re-qualification as per the schedule/plan.

13. To provide Personnel monitoring samples (Finger DAB/ Gowns) to microbiologist after activity as per SOP.

14. To execute Development batches in co-ordination with R&D.

15. Handling of troubleshooting of the Vial/Cartridge filling/sealing machine during operations.

16. Cleaning and operation of Vial/Cartridge filling machine/ sealing machine/lyophilizer/Mobile LAF/ LAF/ Pass box/ Garment Cubicle/SS articles and other associated equipment/instruments in the filling/filtration area as per SOP.

17. Monitoring/ Performing Fogging & cleaning of Aseptic Area/sealing & sterile corridor area.

18. Updating of the status board.

19. Online updating of BMR/ Records/ Checklists/ Logbook as applicable.

20.All documentations to be carried out as per Good Documentation Practices SOP.

21. To ensure that the Preventative maintenance of equipment and instrument has to be performed as per the schedule in co-ordination with maintenance and instrumentation.

22. To report incidents, accidents or any deviations immediately to the supervisors.

23.To participate in annual cGMP / Module/ SOP/ BMR/ Protocol/ Other Trainings (as applicable) and keep online updating of the training record.

24.3. Performing sealing of liquid filled and lyophilized vials as per SOP.

25. To shift the product batch to appropriate cold room for storage.

26. Online entry regarding gas purging for filling machine.

27.Sending sealed containers to packing area.

28. Performing filled volume checks for filled vials/cartridges as per SOP/BMR.

29. Carryout non-viable particle count as per schedule/frequency mentioned in SOP.

30.Operation/ calibration of Weighing balance as per SOP.

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