Role & responsibilities

- To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas.
- Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations.
- To ensure the execution and maintenance of validated status of the injection facility.
- To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents.
- Assuring that the department is in compliance with cGMP/regulatory requirements.
- Co-ordination for new product transfers and thereafter support for process validations.
- Co-ordination with QA for self-inspection and compliance to the audit observations.
- Responsible for improvement in product yield and productivity.
- Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirements.
- To prepare and review capex, user requirement specification etc.
- To prepare and review MIS report and other related documents of production department as per requirements.
- To ensure that initial and continuing training of production persons has been performed as per schedule.
- To confirm the training matrix,



training reports of new and existing employees.
- To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipments.
- Responsible for planning and implementation of preventative and predictive maintenance schedules.
- Overseeing the recruitment, performance of subordinates, mentoring/engaging them to improve their contribution levels.
- Responsible for man management and administrative functions and new Project management.
- Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization.
- Market compliant investigation jointly with QA and other CFT’s.
- To comply and ensure the implementation of safety practices.
- To report that entire daily schedules and executions to the management.
- Responsible for self-Inspection as per schedule.
- Review and approval of QMS elements and process documents through ample logic and EDCS system.
- Review and approval of RM, PM, consumable and other dispensing activities through ERP system.

Preferred candidate profile

📌 Manager Production - Sterile Facility (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh