About the Company We are partnering with a growing pharmaceutical manufacturing organisation operating within a highly regulated GMP environment supporting clinical-stage products and advanced therapeutic programs. The business is focused on establishing scalable manufacturing and quality systems aligned with global regulatory standards. An opportunity is available for a Quality Assurance Associate to support the implementation and ongoing maintenance of a phase-appropriate Pharmaceutical Quality System (PQS) aligned with PIC/S, ICH, and TGA expectations. Key Responsibilities Support supplier qualification activities including vendor assessments, criticality evaluations, quality agreements, and ongoing risk-based reassessments Assist with material management systems including specification management and controlled GMP documentation Author, review, and maintain SOPs, specifications, worksheets, forms, and quality records within the QMS Support quality systems including deviations, CAPAs, change controls, investigations, and document control activities Perform data integrity reviews and support administration of laboratory and manufacturing computerised systems Collaborate cross-functionally with Manufacturing, QC, and Technical Operations to ensure GMP compliance and operational readiness Contribute to continuous improvement initiatives supporting QMS effectiveness and inspection readiness About You Degree qualification in Biotechnology, Pharmaceutical Science, Microbiology, Engineering, or related discipline Experience within a GMP-regulated pharmaceutical, biologics, or manufacturing environment Working knowledge of GMP, GDP, data integrity, and pharmaceutical quality systems Exposure to supplier qualification, deviations, CAPAs, change management, and controlled documentation Familiarity with PIC/S GMP requirements, ICH guidelines, and TGA expectations Strong technical writing skills and high attention to detail Why Apply? Innovative GMP manufacturing environment Technical QA exposure across multiple quality systems Opportunity to contribute to quality and compliance framework development How to Apply If you are seeking a technically focused QA opportunity within a growing GMP manufacturing environment, apply now or contact Ruby on ruby@keselect.com for a confidential discussion. KE Select are specialist recruiters across Life Sciences, Pharmaceuticals, Biotechnology, Medical Devices, and Clinical Research throughout ANZ, Asia, and the UK.
