Aseptic Manufacturing Specialist

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