QC Biosimilar - Assistant Manager

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.

Education: Master's degree

Experience: 5-9 Years

Role & responsibilities

Primary Responsibilities

1. Adherence to cGMP (Current Good Manufacturing Practice), cGLP(Current Good Laboratory Practice) and GDP (Good Documentation Practice).

2. Qualification of Instruments and Equipment (IQ/OQ/PQ) and Facility readiness.

3. Receipt of in process, DS, reserve samples and stability samples, Sample splitting and storage at designated storage location.

4. Planning and performing of In-Process, Finished product (DS) and Stability samples, and reporting the results.

5. Discard of the released batch samples in a timely manner as per waste management SOP.

6. Receipt of chemicals/reagents/consumables, labelling and storage in segregated storage place.

7. Review of analytical reports of In-process, Finished product, Stability, Method Validation, Method Transfer and Study, Review of usage logbooks and Observation data sheets.

8. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.

9. Planning and performing (Testing of method transfer, method validation and study samples. 10. Verification of laboratory compliances, which include the validity checking of the reagents, standards, and equipment status etc.

11. Reporting of Incidents, OOS, OOT and Deviation. Support in closure of the QMS elements.

12. Operation, and monitoring of Analytical equipment. Coordinate with Engineering for timely internal/external calibration, requalification, Preventive maintenance and AMC of equipment.

13. Supporting Operational Excellence, 5S in Quality control Lab.

14. Work for the goals given as part of strategic initiatives 15. Monitoring of EMS/Equipment parameters (Strip chart, Temperature, RH, Differential press

LN2 levels and CO2 levels etc.) and reviewing the reports.

16. Timely update to supervisor on inventory of chemicals/reagents/consumables

17. Involvement in Fumigation and Cleaning activities of laboratory

18) Various monitoring such as lab and equipment and cleaning of labs activities

Secondary responsibilities:

1. Any activity assigned by supervisor/manager apart from the primary responsibilities

2. Supporting to other QC functions when required.

3. Any activity assigned by supervisor/manager apart from the primary responsibilities.