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 QMSin line withcGMPand internal standards
• Supportrecord reviewand quality documentation (including batch records and associated reports)
• Manage/supportchange control, deviations, CAPAand investigations
• Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA)
• Contribute toprocess development and validationactivities for new and existing products
• Provide quality input into planning discussions and continuous improvement initiatives
• Ensure compliance withradiation safetyrequirements and company policies

About you (essential)

• Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciencesor a related discipline
• 5+ years' experiencein quality management within regulated manufacturing (GMP/cGMP)
• Strong knowledge ofcGMPand 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 incGMP radiopharmaceutical manufacturing
• Familiarity withPIC/S / ICHguidelines