Executive/Sr Executive - IPQA Biocon Biologics

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a team member at Biocon Biologics Limited, a subsidiary of Biocon Limited, you will be part of a fully integrated global biosimilars organization dedicated to leveraging cutting-edge science and innovative tech platforms to enhance healthcare outcomes. With a strong research pipeline focusing on biosimilar molecules for diabetes, oncology, immunology, and other non-communicable diseases, we are committed to making treatment more accessible and affordable for patients worldwide. Your responsibilities will include performing line clearance for various manufacturing activities such as formulation, washing, filling, sealing, and others in designated areas. You will also be responsible for reviewing and approving execution reports across different stages of the manufacturing process, including sterilization, filtration, integrity testing, and more. Additionally, you will play a key role in collecting and submitting samples for in-process checks, finished product analysis, and process validation. In this role, you will be expected to review batch manufacturing records, protocols, and other GMP documents to ensure compliance with regulatory standards. You will also be involved in the review and approval of validation/study protocols, reports, master batch records, and SOPs. Furthermore, you will be responsible for investigating complaints, deviations, out-of-specifications issues, and overseeing practices related to media fill, aseptic techniques, microbial monitoring, and clean room maintenance. As part of your duties, you will gain an overview of manufacturing and filling equipment, including utilities such as the water system, HVAC, compressed air, and steam plant. Your attention to detail and adherence to quality standards will be crucial in maintaining the integrity of our manufacturing processes and ensuring the delivery of high-quality healthcare products to our global customer base.,

Posted 2 weeks ago

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Trainee/Officer - Microbiology GLOBAL CALCIUM

0.0 - 4.0 years

0 Lacs

hosur, tamil nadu

On-site

You will be responsible for reporting and reviewing microbiology results of Raw Materials, Packing Materials, In-process Materials, and Finished Products as necessary. Additionally, you will review and approve Microbiological analysis reports including Water, Microbial monitoring of clean rooms, MLT, and BET. Your role will involve preparing SOPs related to QC Microbiology, maintaining media stock and related GPT records, and implementing Good Microbiological Laboratory Practices. You will also review microbial test results of water samples and maintain reference standard cultures/subcultures. Furthermore, you will be expected to prepare miscellaneous validation protocols/reports, MLT & BET method validation protocols/reports, and execute bacterial endotoxin testing/review analytical data and related documentation. Your responsibilities will include trending microbiological results in terms of microbial monitoring of clean rooms/purified water results, equipment qualification/requalification within the Microbiology Lab, and reviewing PRPs and CCPs as per relevant procedures. Key Skills required for this role include validation, microbiology, testing, analytical data review, validation protocols, SOP preparation, microbial monitoring, good laboratory practices, and analysis reports.,

Posted 2 weeks ago

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