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Biocon 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 a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

Responsibilities

• Requisition and receiving BMR (Additional Page) and batch related execution checklists.
• Receiving document number / effective date for technical documents, Protocols and reports.
• Preparation, issuance and archival of logbooks
• Preparation and revision of technical documents, Protocols and reports.
• Receiving technical documents, Protocols, reports and SOP copies, IOC
• Entering of all the logs and documents related to visual inspection area.
• Reviewing of all completed logbook and arranging them in document storage.
• Responsible for the verifying all executed document BMR, Initiation and Review of Change control, CAPA, Event
• Responsible for tracking (CFT review, approval and completion / closure) of Change control, CAPA, Event Initiation of extension
• Handling assigned Change control, CAPA, Event for closure
• Handling of change control, deviations, CAPA in coordination with QA department.
• Involving in the Investigate and closure of deviation.
• Adherence to cGMP (Current Good Manufacturing Practices).
• To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents
• Adherence to Good documentation practices.
• To implement Quality Measurements as per GMP

Qualifications