Assistant Manager - QC Biosimilar

4 - 10 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company, engaged in developing high quality, affordable biosimilars to expand access to cutting-edge therapies globally. As a fully integrated pure play biosimilars organization, Biocon Biologics aspires to transform patient lives through innovative healthcare solutions. With a large portfolio of biosimilars under global clinical development and multiple commercialized products in developed markets, Biocon Biologics believes in the power of strong partnerships to co-create the future of healthcare and positively impact millions of lives. Key Responsibilities: - Adherence to cGMP, cGLP, and GDP standards - Qualification of Instruments, Equipment, and Facility readiness - Handling of in-process, DS, reserve, and stability samples - Planning and performing of various sample testing and reporting results - Disposal of released batch samples as per waste management SOP - Receipt, labelling, and storage of chemicals, reagents, and consumables - Review and analysis of analytical reports and observation data sheets - Preparation and review of method validation, transfer protocols, and reports - Testing of method transfer, validation, and study samples - Verification of laboratory compliances including reagents, standards, and equipment - Reporting and support in closure of incidents, OOS, OOT, and deviations - Operation and monitoring of Analytical equipment, coordinating for calibration, maintenance, and AMC - Supporting Operational Excellence and 5S in Quality control Lab - Monitoring EMS/Equipment parameters and updating supervisor on inventory - Involvement in Fumigation, Cleaning activities, and lab monitoring Qualifications Required: - Education: MSc - Experience: 4 - 10 years with Mandatory Mol Bio Experience preferred Additional Company Details: Biocon Biologics emphasizes the importance of strong partnerships to drive innovative healthcare solutions and aims to create a patient ecosystem beyond products to transform lives. The company's product pipeline includes 28 molecules, collaborating with key partners like Mylan and Sandoz, showcasing a commitment to inclusive healthcare solutions. Visit the company's website for more information: [Biocon Biologics](https://www.bioconbiologics.com),

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