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Process Maintenance- Executive/Senior Executive

2 months ago

Bengaluru, India Biocon Biologics Full time
About the Company

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.

Education : B. Tech( Mechanical)Experience : 3-7 Years

Primary Responsibilities

1. Preparation, Execution & Compilation of PQ, RQ documents for Process Equipment's as per cGMP compliance.2. Revision of approved qualification (i.e., PQ/RQ/Study protocol & Report/Technical Document) document, whenever required.3. Responsible to complete assigned activities as per the defined timelines.4. Equipment qualification, technical documents, Risk assessment and study documents preparation and activity execution.5. Handling and Operation of Data loggers/Wireless sensors for Qualification execution.6. To co-ordinate with the CFT for achieving the day-to-day validation targets.7. Maintenance of all Validation and qualification documents related to B1 and B2 Fill finish.8. Assistance to teammate during validation of all the equipment's present within the production area like the Autoclave, Cold Room, Filling Machines, Sealing Machines, Tunnel, Deep freezer and all new equipment and instruments, automatic vial/cartridge washing machine etc.9. Report incidents or any deviations immediately to the superiors.10. Providing training to CFT for the prepared documents.11. Identification, initiation and closer of discrepancy and change control related to validation activity in eVLMS.12. Review of CFT SOP's comparing with validation documents.13. Responsible for reporting any kind of illness or any abnormal health condition to immediate supervisors so that appropriate action can be taken.14. Adherence to safety, health, hygiene, and environmental measures.15. To strictly adhere to the standard operating procedures and good documentation practice.