Associate Manager

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.

Job Description.

1. Handling of OOS and OOL Investigation related to Environmental excursions and ensure closure of report on time and before batch release as applicable (report preparation, report review and closure). 2. Initiation of CAPA related to OOS and OOL for Environmental excursions and ensure its closure. 3. Keeping online tracking sheet for OOS / OOL. 4. Training of manufacturing personnel on relevantSOP's.5. Ensuring audit Compliance for Fill Finish Production. 5. Ensure the microbial events related to product (Deviations, OOS / OOTs), and microbial water excursion (OOS) investigations are timely conducted, and root cause analysis is identified out and appropriate CAPAs are identified to avoid repeat occurrence. 6. Timely assess the impact due to microbial excursion on the ongoing batches and subsequent batches and propose recommendation to the site. 7. Review of Investigation reports for data furnished for correctness of statements, evidence-based review and ensure no errors in the data and conclusions derived. 8. Involve in management review meetings to present the microbial excursions and status of closures. 9. Provide inputs during trending of microbial related deviations, OOS and propose recommendations and aseptic practise review. 10. Ensure oversight on microbial related investigations, to ensure consistency of global standards, harmonization, sharing of best practice. 11. Drive continuous improvement in microbial investigations to meet and sustain compliance with internal and external regulatory requirements.

Qualifications and Experience

BSc / MSc Microbiology or biotechnology or equivalent experience. 13 + Years Relevant Experience. Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized Strong leadership skill