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 setting. This role will suit a hands-on QA professional who enjoys working closely with operations and documentation to ensure compliance, quality and safety standards are consistently met.
The role
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
Maintain and support the QMS in line with cGMP and internal standards
Support record review and quality documentation (including batch records and associated reports)
Manage/support change control, deviations, CAPA and investigations
Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g. TGA / FDA / EMA)
Contribute to process development and validation activities for recent and existing products
Provide quality input into planning discussions and continuous improvement initiatives
Ensure compliance with radiation safety requirements and company policies
About you (essential)
Tertiary qualification in Chemistry, Engineering, Pharmaceutical Sciences or a related discipline
5+ years’ experience in quality management within regulated manufacturing (GMP/cGMP)
Strong knowledge of cGMP and regulator expectations (TGA/FDA/EMA)
Robust documentation skills; confident with Microsoft Office and QMS-related systems
Ability to work to timelines in a fast-paced environment
Excellent communication and problem-solving skills; confident collaborating across teams
Desirable
Experience in cGMP radiopharmaceutical manufacturing
Familiarity with PIC/S / ICH guidelines
How to apply
Apply with your CV highlighting your QA experience.