Senior Associate Pharmaceutical Quality Assurance Specialist

2 days ago


Tullamarine, Australia CSL Full time
The Opportunity

We are seeking a highly skilled Senior Associate Quality Assurance professional to join our team at CSL Seqirus. As a key member of our Project Banksia team, you will play a critical role in the commissioning, qualification, and validation of our advanced Influenza cell-culture manufacturing facility in Victoria, Australia.

Reporting to the QA Lead, you will be responsible for implementing quality processes and ensuring compliance with regulatory standards. Your expertise will be essential in providing quality assurance oversight for validation activities, protocols, and reports.

The Role

In this exciting role, you will:

  • Provide quality approval for qualification and validation documents related to site processes, equipment, and cleaning.
  • Review qualification and validation documents for compliance against company procedures, regulations, and industry expectations.
  • Collaborate with customers to manage validation deviation records and implement corrective and preventative actions.
  • Support customers with issue resolution and problem-solving.
  • Contribute to 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 of experience in the Pharmaceutical or Biotech industries, with a focus on quality assurance and validation.
  • Experience in a role requiring collaboration, communication, and review of technical documents.
  • Knowledge of quality management systems, regulatory standards, and cGMP.
How to Apply

Please submit your resume and covering letter, addressing the skills and experience above, to R by 10 July, 2024.



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