Shae Amoruso Email & Phone Number

Australia

Melbourne, Victoria, Australia

Working as an R&D Scientist within the Global Expansion team designing and performing laboratory studies required for development and registration of pharmaceutical products (Sterile Injectables) into global markets, and collaboration with Regulatory Affairs for delivery of submission documentation including authoring/review of module 3 dossier sections and responses to regulatory agency questions.

Noble Park, Victoria, Australia

GMP Analytical Chemist performing testing of bulk, finished goods, stability, raw material, cleaning validation and complaint samples, packaging components and method transfer testing.Other key responsibilities included: • QC batch review and release of bulk/finished goods, stability and raw material products, as well as packaging components• Authoring of technical documents including method transfer protocols, change controls, laboratory investigations and LIMS reports• Authoring updates of in-house test methods, work instructions and standard operating procedures