Sr. Executive Syngene International Limited

2.0 - 6.0 years

0 Lacs

karnataka

On-site

The Company Syngene International Ltd. is an integrated research, development, and manufacturing solutions company serving various sectors including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a team of over 4500 scientists, Syngene offers expertise in delivering high-quality science, robust data management, IP security, and efficient manufacturing processes. The company's facilities span over 1.9 million square feet, catering to leading biotech companies and multinational corporations such as GSK and Merck KGaA. Key Responsibilities Safety is a top priority at Syngene, and all employees are expected to prioritize safety in both personal and professional capacities. Compliance with safety guidelines, procedures, and SOPs is mandatory to ensure a safe work environment. Common Responsibilities - 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. Safety And DI Responsibilities - Follow organizational policies on EHSS, POSH, Data Integrity, and IT security. - Wear applicable Personal Protective Equipment (PPE) and adhere to EHS requirements. - Understand and follow safety protocols to prevent incidents. - Identify near-misses and potential incidents, and report them to supervisors. Specific Responsibilities - 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 https://syngeneintl.com/ to learn more about the company and its operations.,

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