Quality and Technical Specialist
Core
Ensuring quality and compliance of complementary medicine and functional food ingredients through vendor qualification, raw material assessment, and technical documentation management within a GMP-regulated environment.
Role type
Quality and Technical Specialist (Scientific Affairs)
Builds
Vendor Qualification Packages, Technical Information Packages, and compliant ingredient supply chains
Domain
Complementary medicine and functional food ingredients
Required skills
GMP knowledge, PIC/S requirements, TGA regulations, technical documentation review, vendor qualification, quality systems management, SOP maintenance, change control, non-conformance management
Preferred skills
Quality system improvement, digitalisation project support
Technologies
GMP, PIC/S, TGA
Responsibilities
Manage and maintain Vendor Qualification Packages and Technical Information Packages; Evaluate raw materials and review technical documentation for quality and compliance; Maintain quality systems, SOPs, change controls, and non-conformance processes; Ensure manufacturer declarations, permits, and certifications remain current; Liaise with suppliers, regulatory bodies, and internal stakeholders; Support vendor assurance activities and product compliance initiatives; Assist with quality system improvements and digitalisation projects
Seniority
Mid-level, hands-on IC
