Manager / Senior Manager

Role & responsibilities :

• Provide leadership to Aseptic Manufacturing Associates of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
• Ensure oversight of Aseptic Manufacturing operations across all shifts, including weekend support as needed.
• Need to have good understanding of HMI, PLC SCADA.
• To be available on shop-floor for production personnel support and compliance oversight.
• Completion of internal batch record review.
• Assist with the authoring and implementation of manufacturing procedures and batch records.
• Lead routine manufacturing activities; including day to day scheduling and raw

materials/consumables management.

• Provide leadership when performing component and equipment preparation, bulk drug formulation, and aseptic filling duties.
• Accurately document data and complete batch records as needed.
• Successfully complete facilitys gowning and media fill qualification program.
• Perform and train other employees in various manufacturing tasks, including, but not limited to: Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
• Operate and assist with the maintenance of production equipment.
• 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 cGMP procedures, and master batch records.
• Assist in the scheduling and performance of routine maintenance and calibration of production equipment.
• Participate in client communications, including problem solving, schedule development, and project status updates.
• Interface with auditors, including client representatives and regulatory agencies.
• Support Agency, customer and vendor audits as needed.
• Perform Manufacturing review and approval of cGMP documentation in support of continuous improvements, including:
• Procedures
• Master Batch Records
• Standard Work Instructions
• Risk Assessment Reports
• Training Curricula

Preferred candidate profile : Bacterial Vaccines / Viral Vaccines / Biologics / Injectable / Insulin

Perks and benefits : As per company norms