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 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 new 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)
Solid knowledge of
cGMP
and regulator expectations (TGA/FDA/EMA)
Strong 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
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📌 Quality Assurance Associate (Brisbane)
🏢 Fuse Recruitment
📍 Brisbane