Senior Associate Quality Assurance Packing Value Stream – Rotating Shift

We are hiring a Senior Associate Quality AssuranceValue Stream to join our team, based at Broadmeadows on an 18-month fixed term basis. You will ensure the appropriate quality of systems and processes, adherence to applicable CSL standards and procedures, review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and monitoring and continuous improvement of quality performance metrics.

You will work on a weekly Rotating Shift roster of 6:39 -14:30 and 14:09 - 22:00.

Reporting to the Senior Manager, Quality Value Stream Packing, you will:

• Supervise, coach and mentor the Quality on the Floor team on rostered shift.
• Ensure adherence to CSL EH&S procedures.
• Provide Quality guidance and point of contact for escalations.
• Support real-time issue resolution for VI and Packing issues using Quality Risk management principles.
• Ensure completion of initial assessment for deviations and participate in Root Cause Analysis sessions.
• Ensure closure of deviations and change controls on time.
• Create and maintain trackers to ensure batch reviews are completely compliantly to meet batch release schedule.
• Complete batch documentation review.
• Roster tasks across shifts to ensure manufacturing and batch release schedules are met.
• Maintain training plans and conduct training to ensure team members are trained to complete their role.
• Lead tiered accountability meetings and ensure handover to next shift.
• Perform QA review and approval of operational, processing and engineering qualification documents to ensure compliance with regulatory requirements as defined in relevant CSL procedures.
• Participate and approve FMEA/QRAs using QRM principles.
• Initiate continuous improvement initiatives to improve compliance and increase efficiencies.

Your Experience:

• A minimum of a Bachelor's Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience.
• Minimum of five (5) years working in a similar role.
• Significant experience in:

o Operational pharmaceutical manufacturing, technical support and manufacturing

o Pharmaceutical Quality and compliance

o Health authority expectations and inspections

o Manufacture and packaging of blood products.

Applications Close 24 April 2024

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