3 - 7 years

0 Lacs

Posted:18 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for ensuring safety as a top priority at Syngene. Compliance with safety guidelines, procedures, and SOPs is essential to maintain a safe work environment. - Adhere to Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for a safe work environment. - Complete assigned trainings in a timely manner and comply with training procedures. - Participate in mandatory trainings related to data integrity, health, and safety. - Maintain compliance with Good Manufacturing Practices and Good Documentation Practices. - Follow Standard Operating Procedures and Operational Control Procedures. - Support training programs on procedures, protocols, and on-the-job activities. - Report nonconformities and deviations to supervisors or line managers promptly. - Participate in deviations, investigations, CAPA, and change controls as needed. In addition to safety responsibilities, you will also have specific responsibilities related to Biologics operations at Syngene: - Adhere to aseptic behavior in Biologics operations. - Perform upstream activities including Assembly preparation, Media Preparation, Vial thaw, Feed preparation, and Bioreactor Operations. - Monitor and control specific Operations of the upstream processes. - Maintain Quality records and traceability of products. - Perform in-process product sampling and storage. - Review and prepare operation-related documents. - Take responsibility for the assigned USP area and equipment/instrument ownership. - Coordinate with QA for line clearance and maintain process areas for inspections. - Prepare procedures, protocols, risk assessments, and Batch Manufacturing Records (BMRs). - Execute protocols related to upstream activities and equipment/instrument qualification. - Review consumable stock and maintenance records. - Ensure timely closure of work orders and report nonconformities. - Participate in downstream activities under the supervision of downstream supervisors. Syngene International Ltd. is an Equal Opportunity Employer. Visit [Syngene International's website](https://syngeneintl.com/) to learn more about the company and its operations.,

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