Senior Investigator/QMS specialist

4 weeks ago

Bengaluru, India Biocon Biologics Full time
Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
Qualification: MSc
Experience: 8-15 years with Mandatory Biosimilar Experience preferred.
Roles and Responsibilities
Experience in biosimilars quality control, with technical knowledge of chromatography, biochemical, and bioassay methods.
Proficient in conducting investigations, performing data analysis, and drawing technical conclusions.
Effective in written and verbal communication.
Familiar with quality guidelines and cGMP systems.
Experience with regulatory audits (such as USFDA, EMA, etc.).
People management experience is considered an additional asset.

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