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.