Assistant Manager - QC Biosimilar

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company focused on developing high quality and affordable biosimilars to provide cutting-edge therapies to patients worldwide. As a fully integrated pure play biosimilars organization, Biocon Biologics aims to improve patient lives through innovative and inclusive healthcare solutions. With a large portfolio of biosimilars in global clinical development and commercialized products in developed markets like EU, U.S., and Japan, Biocon Biologics is committed to transforming healthcare and impacting millions of lives. Your role at Biocon Biologics will involve the following key responsibilities: - Adhering to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice), and GDP (Good Documentation Practice) standards. - Qualifying instruments and equipment (IQ/OQ/PQ) and ensuring facility readiness. - Receiving and handling in-process, DS, reserve, and stability samples, including sample splitting and storage. - Planning and conducting testing of in-process, finished product (DS), and stability samples, and reporting the results. - Disposing of released batch samples according to waste management SOP. - Managing receipt, labeling, and storage of chemicals, reagents, and consumables. - Reviewing analytical reports, usage logbooks, and observation data sheets. - Preparing and reviewing method validation, method transfer, study protocols, stability protocols, and reports. - Performing testing of method transfer, method validation, and study samples. - Verifying laboratory compliances and equipment status. - Reporting incidents, OOS (Out of Specification), OOT (Out of Trend), and deviations, and supporting QMS closure. - Operating and monitoring analytical equipment, coordinating calibration, maintenance, and AMC with Engineering. - Promoting Operational Excellence and 5S in the Quality Control Lab. - Working towards strategic initiative goals. - Monitoring EMS/equipment parameters and reporting on inventory of chemicals/reagents/consumables. - Participating in fumigation, cleaning activities, and various lab and equipment monitoring tasks. Additionally, you may be assigned secondary responsibilities such as supporting other QC functions and assisting with activities as directed by your supervisor or manager. Your role will be crucial in ensuring the quality and compliance of Biocon Biologics" operations. Note: Education qualification required for this position is MSc with 4-10 years of experience, preferably with experience in Molecular Biology.,