The Opportunity

We are looking for a Senior Associate, Operational Services in our manufacturing operations Filling Stream. Reporting to the Operational Services Manager, Compliance and based at our Broadmeadows site, you will facilitate and analyse deviation investigations within manufacturing. This exciting role is a 12-month maternity leave fixed term opportunity.

The Role

• Investigate deviations of any criticality from within the manufacturing area.
• Collaborate with QA and manufacturing to understand the scope and circumstances of the deviation.
• Assemble in conjunction with the direct manufacturing team's information to enable QA to assess risk at SQuIPP impact meetings to meet procedural timeframes.
• Assemble an investigation team and lead the investigation to closure. Manage all documentation from investigation initiation to completion.
• Review and verify the accuracy and completeness of the investigation.
• Communicate investigation and conclusions to key stakeholders and completes any further status updates in collaboration with the QA approver.

• Tertiary Qualification in Sciences or Engineering.
• 5+ years of experience (R&D, Tech Services, Quality or Manufacturing) in a pharmaceutical, biotechnology, or biological industry.
• Demonstrated understanding of cGMP, regulatory requirements and relevant environmental, health and safety requirements as applicable to secondary manufacturing.
• A team player with demonstrated initiative and problem solving, communication skills.
• Ability to engage and influence stakeholders.