QC Bioassay

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 : Masters Degree
Experience : 2-4 Years
Key Skills: Bioassay, Cell Culture, Pharma experience
Primary Responsibilities
1. Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3. Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness.
4. Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5. Preparation, qualification and life cycle management of cell banks used in bioassays.
6. Planning and performing In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
7. Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books 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, system status etc.
11. Reporting and investigation of Incidents, OOS, OOT and Deviation.
12. Supporting Operational Excellence, 5S in Quality control Lab.
13. Calibration of analytical weighing balance, pH meter etc.
14. Various monitoring such as lab and equipment and cleaning of labs activities
15. Performing stability related activity.
Secondary responsibilities (Wherever applicable):
1. Cross functional coordination with all the inter departments for smooth flow of activities.
2. Supporting to other QC functions (QMS, inter sectional activities) when required.
3. Any activity assigned by supervisor/manager apart from the primary responsibilities.

---