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.
Job description:
- Implementation of theoretical knowledge of microbiology, pharmaceutics, pharmaceutical chemistry, Biotechnology and other related pharmaceutical subjects on the workplace.
- Acquainted with current Good Manufacturing Practice, pharmacopeia, different regulatory requirements and drug and cosmetic acts.
- Usage of different sterilization techniques as stem sterilization, heat sterilization, chemical sterilization etc. on work place.
- Ensure quality of drug product at difference stages.
- Ensure data integrity and compliance to quality and regulatory requirements at all times.
- Apply good communication, learning, listening and documentation skills in work place. ,
- To ensure discipline in the team and aseptic practices are compliant always.
- To ensure following of only approved and written procedures in the work place.
- Advanced data analysis; comfort with change, adaptability, and continuous learning; and critical thinking and decision making.
- To assist to production head and any new assessment shall be done as assigned by the production head.
- To coordinate with supporting departments i.e. QA, QC, Engineering & Maintenance, for achieving the day to day production targets and compliance.
- To ensure that the preventive maintenance, re-qualification of all the equipment’s done as per schedule
- To coordinate with compliance team and QA-QMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports.
- To report any departure from the written procedures to your immediate supervisor.
- Apply basic computer skill on day to day data generation and evaluation using different software’s as Microsoft word, excel and power point presentation.
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