The Opportunity

We are looking for a Privigen Filling Team Leader to join our Filling Manufacturing stream. Reporting to the Senior Manufacturing Area Manager, and based at our Broadmeadows Facility, you will lead activities within the Filling team to aseptically dispense a range of therapeutic plasma products and oversee the filling operations inclusive of day to day running, planning, and maintaining QMS systems, procedures, and policies.

This #on-site permanent full-time role is a permanent night shift role working Sunday to Thursday.

The Role

• Conduct activities to meet the filling Schedule to meet Product Release Schedule.
• Actively assist trouble shooting of day-to-day filling related issues.
• Identify and support process development and innovation within the filling area.
• Support the manufacturing plant during technology transfer, capacity upgrades, process development, process optimisation and process standardisation.
• Co-ordinate routine validation and maintenance activities within the Filling Department.
• Ensure timely inventory control of materials is following production requirements and procedures.
• Ensure batch documentation is reviewed within agreed timeline and completed to
• agreed quality standard.

• Tertiary qualification in Sciences, Biotechnology, Chemical/Process, Engineering, Food Science and Technology or relevant experience.
• 3 + years' experience within a pharmaceutical or allied industry involving line Management.
• Strong knowledge and experience in the application of GxP including GMP/GLP/GAMP/GEP and quality management systems like AS/NZS ISO 9001.
• Experience in continuous process and batch operations.
• Experience with quality control and quality assurance systems including an understanding of regulatory guidelines.