Reporting directly to the QA Manager, you will play a critical hands-on role in ensuring the integrity of our clinical trial supply operations. As a QA Specialist, you are the front-line defender of quality, responsible for the day-to-day execution of QMS activities. This role is primarily based at our Sydney facility to support real-time operational inspections and documentation reviews.
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Key Responsibilities:
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Operational QA: Conduct in-process quality checks during packaging and labeling to ensure adherence to batch instructions and SOPs.
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Batch Record Review: Perform meticulous technical reviews of executed batch records and distribution documents for Clinical Trial Materials (CTM).
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QMS Support: Maintain the document control system, training records, and quality archives.
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Compliance Monitoring: Support the investigation of deviations and the implementation of CAPAs to drive continuous improvement.
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Audit Readiness: Ensure all site documentation is in a constant state of "inspection readiness" for sponsor or regulatory audits.
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Essential Experience and Skills:
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Experience: 2-3 years' QA experience within a GMP regulated environment (Pharmaceutical, Biotech, or Clinical Supply).
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Technical Precision:
Exceptional attention to detail with the ability to review complex technical documentation accurately.
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Regulatory Foundation: Strong working knowledge of Australian Code of GMP (PIC/S) and/or Good Distribution Practice (GDP).
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Academic Background: Tertiary qualifications in Science, Pharmacy, or a related field are highly regarded.
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Work Rights Eligibility: Applicants must hold valid, unrestricted Australian working rights.
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Competitive base salary + superannuation.
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Performance-based incentives.
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Full-time or part-time arrangements, with flexible hours to suit project volume.
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In office role based in Sydney.
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About the Business
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ULTRIAL PHARMA SERVICES PTY LTD is a Sydney-based clinical supply services provider delivering end-to-end supply chain solutions for pharmaceutical and biotechnology companies.
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Our services include clinical trial depot operations, GxP-aligned storage, pharmaceutical packaging and labelling, ambient and cold-chain management, import and export coordination, global distribution, returns and destruction, drug accountability and reconciliation, compliant procurement and project support.
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To learn more about our mission and operations, please visit our website: https://ultrialpharma.com/
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📌 Quality Assurance (QA) Officer - Pharmaceutical & Clinical Supply (New South Wales)
🏢 ULTRIAL PHARMA SERVICES
📍 New South Wales
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