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.
Website: https://www.bioconbiologics.com
Roles and Responsibilities:
- Lead the commissioning and qualification of equipment's, ensuring compliance with all engineering and regulatory standards.
- Coordinate with cross-functional teams including project management, QA, and validation to ensure timely execution and compliance.
- Prepare and maintain detailed documentation including protocols, reports, and change controls related to utility systems
- Ensure all systems are commissioned in line with GMP, FDA, and other applicable regulatory guidelines.
- Uphold strict adherence to EHS standards during all utility commissioning and operational activities.
- To carry out planned preventive maintenance on all electrical panels, equipment and its accessories aiming to achieve maximum plant availability with a target of zero unplanned downtime.
- To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part.
- To respond, carry out and record equipment maintenance activity effectively and efficiently.
- Observation and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner.
- Ensure all equipment is operated and maintained as per manufacturer's recommendation.
- Familiarization with the manufacturing process and related equipment.
- To communicate with external vendor for site services/ repair.
- Daily reporting of activities and updating any issues at work to the superior.
- Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ.
- To attend, record and conduct all trainings required as per training matrix/ schedule.
- Generate various document procedure/protocol/report as and when required.
- Fill log sheets/ checklist/ history card/ planner as described in the SOPs.
- Follow the established procedures and policies of the company.
- Participate in project activity on process optimisation, facility upgrade, or objective.
- To propose objectives and targets on work area and comply to set timeline.
- Participate in cost and energy management program.
- On routine basis to provide improvement proposal on equipment, process, or quality system.
- Responsible for data management, trending and periodic presentation.
- To prepare shift scheduling.
- To plan and prepare preventive maintenance activity/schedule.
- To evaluate on vendor performance/ quality/ capability - vendor evaluation/ management process.
