Senior Associate Frontline Quality Assurance

The Opportunity
We’re looking for two Senior AssociatesQuality Assurance (Frontline) to join our team at CSL Seqirus, Parkville (Australia) . In this on-site full-time position, you will provide QA expertise to ensure compliance with the Quality System, cGMP and regulatory guidelines and help investigate deviations and other quality issues. You also will work with colleagues across the site to provide QA advice for the compliant operation of quality processes and provide approval for breakdowns, maintenance works and interventions that have the potential to affect product quality.
These roles are fixed term until 30/6/2025. For existing permanent employees the position may be offered as an ongoing role.
The Role
Reporting to the Manager QA Frontline, you will:

• Review and approve change controls, deviations and CAPAs following the requirements of global and site procedures and regulatory requirements
• Provide Frontline Quality Support to the manufacturing, QC and warehouse teams
• Perform SQuIPP (quality impact) assessments of deviations and other quality issues to ensure risks are assessed and reduced
• Perform root cause analysis, identify CAPA(s) and determine product disposition
• Oversee corrections to data in Quality Applications and help maintain system documentation
• Help prepare reports for the Product Quality Review (PQR) process

Your skills and experience
To be considered for this role, you have:

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, and Biochemistry)
• At least 5 years' GMP experience in pharmaceutical/biotech or other regulated industry including experience of the change control and deviations/investigations process
• At least 1 years' experience working with sterile injectable pharmaceutical products
• Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems
• Experience in a role requiring the communication of complex information including technical writing
• Knowledge of TrackWise, SAP, LIMS and documentation management systems

Please note you will need to adapt your work schedule to meet operational requirements, this may include overtime on evenings and weekends.
How to apply
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-219931 by January26, 2024.
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Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus