Biocon Biologics QC Jobs, Bioassay Position Recruitment – Apply Online
QC Bioassay
Bengaluru, Karnataka, India
About the job
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 the 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: 2-4 Years
Key Skills: Bioassay, Cell Culture, Molecular Biology, Pharma experience
Primary Responsibilities
- Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
- Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice), and GDP (Good Documentation Practice).
- Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness.
- Receipt of in-process, DS, reserve samples, and stability samples and storage at QC location.
- Preparation, qualification, and life cycle management of cell banks used in bioassays.
- Planning and performing In-Process, finished product, and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
- 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.
- Preparation and review of method validation, method transfer, study protocol, stability protocols, and summary sheet (Compilation Data) and reports.
- Planning and performing (Testing) of method transfer, method validation, and study samples.
- Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status, etc.
- Reporting and investigation of Incidents, OOS, OOT, and Deviation.
- Supporting Operational Excellence, 5S in Quality Control Lab.
- Calibration of analytical weighing balance, pH meter, etc.
- Various monitoring such as lab and equipment and cleaning of lab activities.
- Performing stability-related activity.
Secondary Responsibilities (Wherever Applicable):
- Cross-functional coordination with all the inter-departments for smooth flow of activities.
- Supporting other QC functions (QMS, inter-sectional activities) when required.
- Any activity assigned by supervisor/manager apart from the primary responsibilities.
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