Scientific Officer

4 weeks ago

Chandigarh, India Panacea Biotec Full time

Job Responsibilities: - Supervise and coordinate the activities of the filling line team, including operators, technicians, and other personnel. - Ensure the efficient and compliant operation of vial washing, depyrogenation tunnel, and filling machines (Groninger and BOSCH). - Enforce adherence to cGMP guidelines, national regulations (Schedule M), and international standards (WHO) across all filling operations. - Oversee the training and development of filling line personnel on aseptic techniques, equipment operation, and documentation practices. - Monitor and evaluate the performance of team members, providing regular feedback and conducting performance reviews. - Create and maintain staff schedules to ensure adequate coverage and efficient workflow. - Troubleshoot operational issues, resolve conflicts, and escalate complex problems to management as needed. - Participate in the investigation of deviations, implementation of corrective actions, and continuous improvement initiatives. - Collaborate with other departments, such as Quality Assurance, Maintenance, and Engineering, to ensure smooth and efficient operations. - Contribute to the development and revision of SOPs, BMRs, and other relevant documentation. - Ensure the proper completion and review of all batch records and associated documentation. - Oversee the qualification (IQ/OQ/PQ) of filling line equipment and participate in process validation activities. - Manage the calibration and verification of equipment, including weighing balances and other critical instruments. - Monitor environmental conditions in the filling area and ensure compliance with established standards. - Maintain inventory of necessary supplies and materials for the filling line. - Ensure compliance with all safety protocols and procedures. - Stay updated on industry best practices and regulatory requirements related to aseptic processing and filling operations. Qualification: M.Sc (Mirobiology / Biotechnology) / B.Pharma Experience: 3-5 Years

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