Biocon Biologics | DP Compliance
4 weeks ago
Role & responsibilitiesPrimary Responsibilities1. Physical/ CCTV monitoring & review of Aseptic practices during Batch manufacturing (Filling machine assembling/ Filling activity/ Handling of aseptic interventions/ Lyophilizer loading / Handling of product contact container & closures/ Environmental monitoring & cleaning of filling machine).2. Monitoring of Aseptic area cleaning by operators.3. Monitoring and review critical parameters of the processes of the sterile products.4. Participate in regulatory audits and ensure audit compliance.5. Verification of aseptic area activity logbook & entry/exit and ensure its compliance.6. Identify gaps as per current regulatory requirements and support for implementation ofappropriate corrective actions.7. Training of the Aseptic operators in Aseptic Practices, Aseptic behavior and Good Documentation Practices on a continuous basis.8. Perform investigations for deviations related to Aseptic area Practices / Aseptic handling Procedures and close the deviations as per the timelines.9. Preparation & review of SOP pertaining to Aseptic areas.10. Appraise the manufacturing operators at regular intervals with latest changes in regulatory requirements
Secondary Responsibilities1. 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 relevant SOPs.5. Ensuring audit Compliance for Fill Finish Production.6.Risk assessment handlings (1400-Quality-QA30343).7. Review of JOS, TTDs and other technical documents and coordinating with R& D.8. Any other assignment assigned by Head of Department
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Bengaluru, India Biocon Biologics Full timeBiocon Biologicsis 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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DP Compliance
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