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.
