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Broadmeadows

    Senior Associate Pharmaceutical Quality Assurance - Broadmeadows, Australia - CSL Behring

    CSL Behring
    CSL Behring Broadmeadows, Australia

    2 weeks ago

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    Description

    The Opportunity

    We are in search of a skilled Senior Associate Quality Assurance professional to join the CSL Behring Quality team based in Broadmeadows, Australia, for a fixed-term position until July 31, 2025 (covering maternity leave). Reporting to the Manager QA Value Stream Release, you will be responsible for reviewing batches of intermediate, semi-finished, and finished products and approving their release. Additionally, you will assist in assessing quality issues post-release, involving Product Technical Complaints (PTC) and Adverse Event Investigations (AE).

    The Role

    Located on-site in Broadmeadows and collaborating with a diverse team, your responsibilities will include:

    • Reviewing relevant product portfolio batch/release documentation to ensure product suitability for further processing or release, and reporting identified issues;
    • Conducting detailed reviews of batch records for starting materials, intermediate, and final products;
    • Managing batch dispositions of plasma, intermediates, and semi-finished products, including SAP transactions and necessary documentation;
    • Coordinating PTC investigations and Adverse events to determine root causes and necessary corrective actions;
    • Participating in internal and regulatory inspections to ensure compliance;
    • Handling SAP master data management for QA release;
    • Providing training to value stream production partners;
    • Collaborating with other Quality teams across the network in Batch Release to enhance and standardize quality processes and standards.

    Your skills and experience

    • A Bachelor's Degree in relevant fields or equivalent qualifications/experience;
    • Over 5 years' experience in a similar role in pharmaceutical or regulated manufacturing industries;
    • At least 3 years of experience with GxP and local/international regulatory requirements (e.g., TGA, FDA);
    • Proven experience in making risk-based quality decisions with appropriate justifications;
    • Familiarity with TrackWise or Veeva and electronic document management systems (eDMSs).

    How to apply:

    To apply, submit your resume and cover letter (combined into one document), addressing the specified criteria and including reference number R by May 19, 2024.

    Our Benefits

    Prioritize your well-being with us. Learn more about how we support you at CSL.

    About CSL Behring

    CSL Behring specializes in developing and delivering high-quality medications for individuals with rare and severe diseases worldwide. Our treatments provide hope for patients in over 100 countries facing immunological, hematological, cardiovascular, metabolic, respiratory, and transplant-related conditions. Explore more about CSL Behring.

    Inclusivity at CSL

    Operating globally with employees across 35+ countries, CSL values diversity and inclusion. Discover more about Diversity & Inclusion at CSL.

    Make an Impact at CSL Behring

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