Scientific Officer (Production)

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