Quality Control Analyst

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.

Requirement

Skills required: Handling of HPLC, CESDS, UHPLC, iCIEF Maurice, Osmometer and Solo VPE.

Education: M.Sc.(Bio Chemistry/Biotechnology)

Experience: 2-4 Years

Primary Responsibilities

• Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
• Receipt of in process, DS, reserve samples and stability samples and storage at QC location
• Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies, and reporting the results.
• Handling of HPLC, CESDS, UHPLC, iCIEF Maurice, Osmometer and Solo VPE.
• Review of analytical reports of In process, finished product, stability, method validation, method transfer and study, Review of usage log books, preparation log books and Observation data sheets.
• Preparation and review of method validation, method transfer, study protocol 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.