Senior Manager Production - Sterile Facility

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/motivating 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