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.
https://www.bioconbiologics.com
Role & responsibilities
Role Summary:
- Preparation, review and closure of QMS elements (CAPA, Change management, Deviation, PM, Communication Memo)
- Preparation/review of qualification documents, validation, PM planner, memos, training materials
- Support FAT/SAT/DQ/IQ/OQ/PQ activities
- Generate/support required documents
- Managing shift operations effectively
- Taking accountability for all shift activities
- Working in shifts and supporting operations during critical breakdowns
- Execute planned preventive maintenance to achieve zero unplanned downtime
- Raise preventive maintenance communication memo
- Maintain spare part availability
- Perform planned/unplanned maintenance
- Detect unusual equipment conditions proactively
- Ensure equipment operation per manufacturer recommendation
- Report daily activities and issues
- Support FAT/SAT/DQ/IQ/OQ/PQ
- Conduct required trainings
- Fill log sheets/checklists/history cards
- Participate in audits and close findings
- Prepare shift scheduling
- Issue work permits/gate pass
- Attend mandatory GMP/GDP/GLP/Data Integrity/Microbiology training
- Ensure documentation accuracy per ALCOA principles
- Coordinate document control procedures
- Maintain updated registers and controlled documents
- Review and update technical documents
- Ensure smooth internal/external audits
- Track QMS elements and overdue items
- Support FAT/SAT/DQ/IQ/OQ/PQ activities
Qualifications & Skills:
- Education: BE/B.Tech in Mechanical.
- Experience: 7 to 13 years
