Head Production – Sterile | Immacule Lifesciences | Nalagarh

Job Description

  • To ensure and maintain the work discipline on the shop floor.
  • Planning and execution of monthly manufacturing/packing plan and other manufacturing/packing activities.
  • Responsible for production-related tasks including production planning and process control and troubleshooting for achieving the planned periodic schedules.
  • 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 the overall operations.
  • To ensure the execution of the validated status of the injection facility.
  • To ensure the 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 validation
  • Coordination with QA for self-inspection and compliance to the audit observation.
  • Responsible for improvement in product yield and productivity.
  • Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirement.
  • To prepare and review CAPEX, user requirement specification, etc.
  • Prepare and review MIS reports and other related documents of the production department as per requirement.
  • To ensure that initial and continuing training of production persons has been performed as per schedule.
  • To confirm the training matrix and training reports of new and existing employees.
  • To ensure scheduled validation of the equipment, calibration of devices, and maintenance of equipment.
  • Responsible for planning and implementation of preventative and predictive maintenance schedules.
  • Overseeing the recruitment, and performance of subordinates, mentoring/motivating them to improve their contribution levels.
  • Responsible for man management and administrative functions.
  • Responsible for implementation of systems, processes, and procedures to facilitate smooth functioning of overall operations and enhance operational efficiency and cost optimization.
  • Market complaint investigation jointly with QA.
  • To comply and ensure the implementation of safety practices.
  • To report the entire daily schedules and executions to the management.
  • New Project management.
  • Review and approve of QMS elements and process documents through Ample logic and EDCS system.

Qualification: B.Pharma, M.Pharma

Location