Executive/Sr Executive - IPQA

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.

RESPONSIBILITIES:

1. Performing line clearance for formulation, washing, filling, sealing and other activities in manufacturing areas.
2. Review and approval of execution reports during formulation, sterilization, filtration, filling, Sealing, integrity testing, reconciliation etc.
3. Collection and submission of samples for in process, finished product and process validation.
4. Review of Batch manufacturing records, protocol and other GMP documents.
5. Review and approval of validation/study protocol, reports, master batch records, SOPs etc.
6. Investigation of complaints, deviations, out of specifications, etc
7. Overview of media fill, aseptic practices, microbial monitoring, clean room maintenance etc.
8. Overview on manufacturing and feeling equipment including utilities like Water system, HVAC, compressed air, Steam plant, etc.