Assistant Manager

2 weeks ago

India Biocon Biologics Full time

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

  • Bachelor's or master's degree in pharmacy , Life Sciences, Biotechnology, Chemistry, or B.Tech or M.Tech related discipline.
  • 8+ years of retail or equivalent management experience
  • Strong verbal or written communication skills

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