QA & Microbiology Manager
Core
Lead quality, microbiology, and regulatory compliance in a complex manufacturing environment to ensure products are fit for purpose.
Role type
Senior IC Quality Assurance & Microbiology Manager
Builds
Pharmaceutical and agricultural chemical products under TGA regulation
Domain
Regulated manufacturing (Pharmaceuticals/Agrochemicals)
Required skills
Quality Management Systems (QMS), GMP compliance, microbiological testing, environmental monitoring, CAPA management, audit leadership, regulatory affairs (TGA, ISO 22716, BRC), team leadership
Preferred skills
Bachelor's degree in Pharmacy with Pharmaceutics and Microbiology majors, validation of manufacturing systems, Product Quality Reviews (PQRs)
Technologies
TGA-GMP, ISO 22716, APVMA, BRC, ACO, RSPO, EPA
Responsibilities
Lead and continuously improve the site Quality Management System (QMS), Drive GMP compliance across the manufacturing operation and laboratory, Manage the QC testing laboratory and onsite microbiological testing activities, Lead environmental monitoring and cleaning validation programs, Manage investigations, deviations, out-of-specification results and CAPA, Lead and coordinate site audits and product recalls, Lead, coach and develop QA/QC and microbiology team members
Seniority
Senior, hands-on IC