
Scientific Officer
2 days ago
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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