Senior Associate Quality Assurance (QA) Validation

CSL

Location: Parkville

Job Type: Full time

Posted

Perfection not required
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Job Description

The Opportunity

We are looking for a Senior Associate Quality Assurance (QA) Validation to join our growing Project Banksia team constructing our advanced Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia's public health needs such as snake and spider antivenoms.

Based at Tullamarine and reporting to the QA Lead, in this full-time fixed term role, until 30 September 2026, you will help implement quality processes during the commissioning, qualification and validation of the Tullamarine and Woodend facilities. You will also provide QA expertise and ensure all processes and documentation remain compliant.

The Role

In this interesting role you will:

  • Provide quality approval for a variety of qualification and validation related documents for site processes, equipment, cleaning and critical utilities;
  • Provide quality assurance oversight for validation activities, protocols and reports performed by the engineering and validation teams;
  • Review qualification and validation documents for compliance against company procedures and regulations and industry expectations;
  • Work with customers to manage the completion of validation deviation records including identifying root cause(s) and implement appropriate Corrective and Preventative Actions (CAPAs);
  • Support customers with issue resolution and problem solving;
  • Support implementation of "best practice" validation activities and incorporate into the quality review process.

Your skills and experience

To be considered for this role you have:

  • A Bachelor's degree in an Engineering or Science related field;
  • 5+ years' experience in the Pharmaceutical or Biotech industries, in a similar or related role;
  • 5+ years' experience applying or overseeing validation principles to manufacturing processes, equipment and cleaning;
  • Experience in a role requiring collaboration, communicating complex information and reviewing technical documents;
  • Experience in an organisation operating under a Quality Management System and within local and international Regulatory Standards, Quality Risk Management and cGMP;
  • An understanding of quality assurance, quality control and validation.

How to apply:

Please send us your resume and covering letter (in one document), which addresses the skills and experience above and includes reference number R-184200 by October 5, 2022

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.

About 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.

We want Seqirus to reflect the world around us

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

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