Senior Associate Pharmaceutical Quality Assurance

3 weeks ago

Tullamarine, Australia CSL Full time

The Opportunity

We are looking for a Senior Associate Quality Assurance (QA) 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, the role 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.

This role is fixed term ending 30th June 2026 , depending on your current employment status.

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, regulations and industry expectations. Help review and maintain system documentation. 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:

Bachelor's degree in an Engineering or Science related field; 3+ years' experience in the Pharmaceutical or Biotech industries, in a similar or related role; 3+ 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-232269 by 10 July, 2024.

#LI-ONSITE

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.

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