The Opportunity
Are you passionate about ensuring product quality and compliance? We're looking for an experienced Senior Associate, Frontline Quality Assurance (Deviations) to join our inclusive and dynamic team at Seqirus, Parkville (Australia). Our Quality Assurance (QA) function plays a crucial role to help maintain the highest standards of quality and safety.
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 will also collaborate with colleagues across the site to provide QA advice for the smooth operation of quality processes and provide approval for breakdowns, maintenance works, and interventions that have the potential to affect product quality.
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This is a fixed-term opportunity until December 2025.
The Role
Reporting to the Manager QA Frontline, you will:
- Review and approve deviations and CAPAs, ensuring compliance with global and site procedures and regulatory requirements.
- Perform quality impact assessments of deviations and other quality issues, ensuring risks are identified and minimized.
- Accomplish detailed root cause analyses, identify CAPAs, and determine product disposition to maintain the highest quality standards.
- Use your QA expertise to oversee shopfloor activities, ensuring quality is maintained across all business operations.
- Approve maintenance works and interventions that could impact product quality, safeguarding our standards.
- Implement continuous improvement projects to enhance product quality and operational efficiency.
- Prepare reports for the Product Quality Review (PQR) process, contributing to our ongoing quality assurance efforts.
- Review and approve GMP documents, ensuring all processes follow Good Manufacturing Practices.
Your Experience
To be considered for this role, you have:
- A university degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, Biochemistry).
- 5+ years' GMP experience in pharmaceutical/biotech or other regulated industry.
- 3+ years' experience in deviations/investigations process and in a Quality Operations role within the pharmaceutical industry.
- Experience in Quality decision-making on the shopfloor (preferred)
- Familiarity 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, analysis, and accuracy.
- Knowledge of TrackWise, SAP, LIMS, and documentation management systems.
Join us in shaping the future of quality assurance and making a difference in patients' lives. Apply now and be part of our mission to deliver safe products to the world.
Please apply with your covering letter addressing to your key selection criteria and your resume by 10th October 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