A leading organisation in the radiopharmaceutical manufacturing space is seeking a Quality Assurance Associate to support the implementation, maintenance and continuous improvement of a Quality Management System (QMS) in a cGMP-regulated environment. This role will suit a hands-on QA qualified who enjoys working closely with operations and documentation to ensure compliance, quality and safety standards are consistently met.
The role n
You’ll partner with cross-functional teams to support quality and regulatory compliance across the product lifecycle, including support for equipment transition and facility activities such as validation and verification .
Key responsibilities n
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Maintain and support the QMS in line withcGMP and internal standards
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Supportrecord review and quality documentation (including batch records and associated reports)
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Manage/supportchange control, deviations, CAPA and investigations
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Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA )
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Contribute toprocess development and validation activities for current and existing products
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Provide quality input into planning discussions and continuous improvement initiatives
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Ensure compliance withradiation safety requirements and company policies
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About you (essential) nn
Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciences or a related discipline
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5+ years’ experience in quality management within regulated manufacturing (GMP/cGMP)
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Strong knowledge ofcGMP and regulator expectations (TGA/FDA/EMA)
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Strong documentation skills; confident with Microsoft Office and QMS-related systems
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Ability to work to timelines in a fast-paced setting
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Excellent communication and problem-solving skills; confident collaborating across teams
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Desirable nn
Experience incGMP radiopharmaceutical manufacturing
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Familiarity withPIC/S / ICH guidelines
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