KE Select
Quality Assurance Associate
Job Description
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, for...