Job Description

The Opportunity

Seqirus, part of the CSL Family, is a leader in egg-based influenza vaccine manufacturing, in-licensed vaccines and specialty pharmaceuticals, we are also the sole supplier of a unique range of products made in the national interest for the Australian Government. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats.

We are looking for a full-time Senior Associate, Quality Assurance (QA) to join our diverse Batch Release team in Parkville (Australia). This will be a fixed term position until 30/6/2025. You will support the batch release of flu products, ensure ongoing compliance with domestic and international regulatory standards. You will also support Product Technical Complaints (PTCs) and provide QA expertise to the manufacturing and quality control teams to support site outcomes.

The Role

Reporting to the Manager QA Batch Release and based on-site, you will:

• Review manufacturing documentation to ensure that raw materials, intermediates, and final products are suitable for further processing or release, and follow documented batch process sheets/procedures;

• Support maintenance of quality systems relating to batch release of finished products and manufacturing intermediates and PTCs;

• Maintain the Seqirus Product Technical Complaint (PTC) Inbox

• Perform SQuIPP assessments for PTCs to ensure risk is assessed promptly

• Manage investigation process to closure for PTCs and other quality issues, working with

• Participate in regulatory audits and projects;

• Identify and implement continuous improvements across Batch Release.

Your skills and 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;

• Experience applying current Good Manufacturing Practices (cGMP) principles;

• Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems;

• Experience working with quality and manufacturing teams to achieve outcomes

• Experience in a role requiring analysis and accuracy;

• Experience completing goals within established time frames;

• Knowledge of TrackWise, Veeva, SAP, LIMS and documentation management systems.

Please note you will work a rotating shift pattern in this role.

How to apply

Please send us your resume and cover letter (in one document), which addresses the skills and experience above and includes reference number R-212935 by 3 October, 2023.

About Us

Our Benefits

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 Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.