Quality Assurance (QA) Officer – Pharmaceutical & Clinical Supply
ULTRIAL PHARMA SERVICES PTY LTD – Bankstown NSW
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.
Key Responsibilities:
Operational QA
: Conduct in-process quality checks during packaging and labeling to ensure adherence to batch instructions and SOPs.
Batch Record Review
: Perform meticulous technical reviews of executed batch records and distribution documents for Clinical Trial Materials (CTM).
QMS Support
: Maintain the document control system, training records, and quality archives.
Compliance Monitoring
: Support the investigation of deviations and the implementation of CAPAs to drive continuous improvement.
Audit Readiness
: Ensure all site documentation is in a constant state of "inspection readiness" for sponsor or regulatory audits.
Essential Experience and Skills:
Experience:
2-3 years' QA experience within a GMP regulated environment (Pharmaceutical, Biotech, or Clinical Supply).
Technical Precision
:
Exceptional attention to detail with the ability to review complex technical documentation accurately.
Regulatory Foundation:
Strong working knowledge of Australian Code of GMP (PIC/S) and/or Good Distribution Practice (GDP).
Academic Background:
Tertiary qualifications in Science, Pharmacy, or a related field are highly regarded.
Work Rights Eligibility
: Applicants must hold valid, unrestricted Australian working rights.
Competitive base salary + superannuation.
Performance-based incentives.
Full-time or part-time arrangements, with flexible schedule to suit project volume.
On-site role based in Sydney.
About the Business
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.
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.
To learn more about our mission and operations, please visit our website: /
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