Senior Quality Associate, China (Parental Leave Cover)
Core
Ensure end-to-end quality operations for New Product Development (NPD) and Existing Product Development (EPD) projects, managing specifications, stability, and compliance for pharmaceutical and complementary medicine products.
Role type
Senior Quality Associate (Regulated Manufacturing)
Builds
Compliant commercial batches of nutrition and medical products
Domain
Pharmaceutical/Complementary Medicine Manufacturing
Required skills
Root cause analysis, Change control management, Stability program management, Document control, Supplier qualification, GMP compliance, Risk assessment, Complaints management, Laboratory operations
Preferred skills
Mandarin language proficiency, Travel within Sydney and interstate
Technologies
Microsoft Office (Word, Excel), Quality Management Systems
Responsibilities
Sign off product specifications for new and existing products; Manage change controls and stability protocols; Liaise with contract manufacturers regarding non-conformances; Arrange external contract testing; Participate in supplier qualification and GMP agreement reviews; Prepare metrics for Management Review; Lead deviation and OOS/OOT investigations.
Seniority
Senior, hands-on IC
