- Responsible for manufacturing & packaging operations of sterile infusion bags (formulation, filling & packaging) and Warehouse operations.
- This position works closely with Quality Assurance, Quality Control, Engineering and other relevant teams at site.
- Responsible for developing, implementing, and maintaining an effective & productive manufacturing system by maintaining quality and reliability in the product & processes.
- Supervisory Responsibilities:
• Hires and trains production & warehouse staff
• Oversees the daily workflow and schedules of the department.
• Conducts performance evaluations that are timely and constructive.
• Handles discipline in accordance with company policy.
- Duties/Responsibilities
• Responsible for all production & warehouse operations for infusion bags manufacturing across all shifts, including weekend support as needed.
• Responsible for developing & reviewing all production records.
• Client support / interaction related to these processes.
• Assist with the authoring and implementation of manufacturing procedures and batch records.
• Lead routine manufacturing activities; including day to day scheduling and raw materials / packaging materials /consumables management etc.
• Accurately document data and complete batch records as needed.
• Successfully complete facility’s gowning and qualification program.
• Perform and train other employees in various manufacturing tasks, including, but not limited to: component preparation, formulation operations, filling operations, packaging, and warehouse procedures etc.
• Perform duties in cleanroom areas and help to maintain those areas.
• Ensure personnel are trained on all applicable procedures and master batch records prior to execution.
• Initiate revisions to GMP procedures, and master batch records.
• Participate in qualification & validation activities for production equipment and ensure the validated status of production equipment.
• Perform Risk Assessment of all production equipment, processes and systems in coordination with QA & HSE team.
• Develop production & warehouse operations related SOPs and ensure its proper implementation.
• Ensure daily, weekly, monthly product delivery schedules are met on time.
• Proper management of departmental budget.
• Assist in the scheduling and performance of routine maintenance and calibration of production equipment.
• Control & monitor all warehouse operations including material receipt, product dispatch, inventory etc.
• Responsible for maintaining safety in the department aiming at zero accidents.
• Perform all other tasks, projects, and duties as assigned by Senior Team.