Biocon Biologics | Manager
2 weeks ago
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: Bachelor's degree, master's degree
Experience: 15+Years
Role & responsibilities
Primary Responsibilities
- To govern the start to end activities related to shipping validations for various product portfolio across the globe which triggers from regulatory, quality, partners/CMOs/improvement initiatives etc.,
- To manage shipping related notifications for temperature excursions, investigation for shipments crossed the established TOR limit and other non-compliances. To liaise with QA and other CFTs to timely closure of SRNs/Deviations and facilitate timely immediate disposition of batches to ensure product availability in market & patients.
- To understand the validation deliverables with regulatory and quality team and ensuring the same for timely completion to fulfil product filing.
- To enable various cost effective and improvement projects through risk assessment and QMS documents.
- To host and lead regulatory/customer audits to aim zero critical and major observations. To provide response to the audit observations and ensure it for timely closure.
Secondary Responsibilities
- Ensure all QMS, SOPs and qualifications are delivered on time without any extensions.
- Initiate, Plan, review, track progress & measure QMS performance in line with approved SOPs/regulations and appropriate quality tools.
- Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities.
- Identify potential risks and develop strategies to mitigate them.
- To present FG -Logistics compliance functions to Senior leadership on monthly basis.
- To ensure all digital projects are effectively implemented with CFT collaboration.
- Handle regulatory, customer/consultants/Internal, statutory and safety audits and ensure compliance.
- To review URS, Risk Assessment, Impact Assessment, Protocols, and Reports for the equipment and facility qualification.
- Establishing and review of EHS objectives, targets and management programs in the department.
- To support quality team regarding QMS review, PQRs, Trend report, facility review reports etc.
- Timely escalation of the issues to senior management with respect to quality and safety.
- To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines.
- To ensure mandatory and periodic training are completed for self and team.
- Adhere to the company's policies and ensure to align the warehouse activities to meet the company's business goals.
- To provide timely response to all QA internal/external audit and implement CAPA holistically
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bangalore, India Biocon Biologics Full timeAbout 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...
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bangalore, India Biocon Biologics Full timeAbout the Company 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...
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bangalore, India Biocon Biologics Full timeAbout the Company 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...
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bangalore, India Biocon Biologics Full timeAbout the CompanyBiocon 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...
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bangalore, India Biocon Biologics Full timeBiocon Biologics is a fully-integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics...
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bangalore, India Biocon Biologics Full timeBiocon Biologics is a fully-integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is...
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bangalore, India Biocon Biologics Full timeAbout the CompanyBiocon 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...
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bangalore, India Biocon Biologics Full timeAbout 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...
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bangalore, India Biocon Biologics Full timeAbout the CompanyBiocon 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...
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