Senior Quality Associate
Core
Senior Quality Assurance Associate supporting GMP compliance, contract manufacturing oversight, and quality improvement initiatives for a global healthcare organization's Australian business.
Role type
Senior IC Quality Assurance Associate
Builds
Quality systems and compliance processes for external contract manufacturing partners
Domain
Healthcare / Pharmaceuticals / Quality Assurance
Required skills
GMP compliance, CAPA management, validation activities, SOP development, regulatory knowledge (Australian TGA), contract manufacturer oversight, quality investigations, process improvement
Preferred skills
Stakeholder engagement, training delivery, continuous improvement methodologies
Technologies
GMP, CAPA, TGA regulations, validation protocols
Responsibilities
Support Quality oversight and compliance activities across external contract manufacturing partners; Conduct and support Quality investigations, non-conformances and CAPA management; Coordinate and support validation activities to ensure compliance with GMP and regulatory requirements; Review, develop and implement Quality procedures aligned with Australian TGA requirements; Identify opportunities to streamline processes and strengthen local Quality systems; Develop and deliver Quality training, workshops and educational initiatives across the business
Seniority
Senior, hands-on IC
