Senior Manager

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.

https://www.bioconbiologics.com

Education Qualification:

Experience: 15+

Role & responsibilities

• Review and approve market complaints in TW and QRN approvals.
• Assist the team in investigating MC and QRN to identify root causes.
• Provide support for identification and assessment of market complaints.
• Review and approve MC and QRN trend reports.
• Review and approve CAPA projects ensuring all actions are implemented as intended.
• Assist the team in CAPA review/approval process.
• Review and approve CAPA & EC trends (half-yearly).
• Approve extensions and interim reports.
• Review and approve major QMS deviations in TW.
• Assist investigations and identify proper CAPA.
• Review and approve deviation trends.
• Approve extensions and interim reports.
• Review and finalize monthly data submitted for MRM, JQC, and QMF meetings.
• Adhere to cGMP (Current Good Manufacturing Practices).
• Follow good hygiene practices and report illness/unhygienic incidents.
• Identify personnel.
• Adhere to good documentation practices.
• Implement quality measurements as per GMP.
• Maintain QA documents and coordinate with other departments.
• Verify documents and annexures for completeness and correctness after activity completion.
• Identify, analyze, and control risk.
• Manage communication and coordination of regulatory/customer audits.
• Write responses to regulatory/customer audit reports.
• Initiate and close CAPA reports for regulatory/customer audits.
• Monitor and follow up for closure of regulatory/customer audit CAPAs.
• Review and ensure revised procedures align with regulatory audit commitments.
• Evaluate and verify effectiveness of implemented regulatory/customer audit CAPAs.
• Coordinate with regulatory functions and support documentation for regulatory agencies/customers.