Senior Associate Pharmaceutical Quality Assurance Specialist
2 weeks ago
The Opportunity
We are seeking a skilled Senior Associate Quality Assurance professional to join our team at CSL Seqirus, a leading manufacturer of influenza vaccines and other critical healthcare products. As a key member of our Project Banksia team, you will play a vital role in the commissioning, qualification, and validation of our advanced manufacturing facilities in Australia.
Based at our Tullamarine site, you will report to the QA Lead and be responsible for implementing quality processes, providing QA expertise, and ensuring compliance with regulatory standards and company procedures. This is a fixed-term role, ending on 30th June 2026, depending on your current employment status.
The Role
In this exciting role, you will:
- Provide quality approval for qualification and validation documents related to site processes, equipment, cleaning, and critical utilities.
- Provide QA 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 validation deviation records, including identifying root causes and implementing CAPAs.
- Support customers with issue resolution and problem-solving.
- Support the implementation of best practice validation activities and incorporate them into the quality review process.
Your Skills and Experience
To be considered for this role, you will have:
- A 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 submit your resume and covering letter (in one document), addressing the skills and experience above, to CSL Seqirus.
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