Ann Bui

Background

About Ann Bui

A transformational and dynamic quality project leader with a demonstrated ability to drive positive change and build a strong quality culture. Spearheaded the design and implementation of a risk-based contamination control strategy, cleaning and disinfection program and environmental monitoring program for a state of the art bulk biologics facility built on automation controls and cutting-edge technology. Provided quality oversight during the commissioning, qualification and validation of aseptic manufacturing processes, systems and facilities to ensure the highest level of sterility assurance is achieved. Well versed in quality assurance and quality control for the food and pharmaceutical industries including aseptic processing and terminal sterilization of pharmaceuticals, biologics and medical devices. Led several compliance and quality remediation activities including the harmonization of processes with industry standards including ICH, Annex 1, ISO, PDA, CFR and USP.