DP Maintenance - Malaysia Employment - PVP

Job description

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** **Roles and Responsibilities** - 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.