With more than 22 years of experience in Computerised Systems Validation, Engineering Compliance, and GMP consulting, I am a seasoned pharmaceutical professional located in Brisbane, Australia. As a proficient Computerised Systems Validation Engineer, I specialise in employing a risk-based Computer Software Assurance approach to fulfill Data Integrity requirements within the Pharmaceutical and Medical device sectors.Currently serving as Senior Computer Systems Validation Engineer at Vaxxas, I facilitate the adoption of new technologies from development into the manufacture of vaccine and medical device combination products, ensuring compliance with regulatory standards in Computerised Systems Validation (CSV) and Data Integrity (DI).Previously, as a consultant at Sterling Process, I provided comprehensive GMP consulting services across various facilities, focusing on computer validation governance and oversight.Prior to joining Vaxxas, I served as the Engineering Compliance Manager at Viatris (formerly Mylan), demonstrating strong leadership skills while overseeing engineering quality and compliance obligations at the Carole Park site. My responsibilities included validation and qualification, risk management, change management, incident investigation, CAPA management, and staff supervision.During my 17-year tenure at GlaxoSmithKline, I held a pivotal role as the head of the corporate Global Computer Validation team in South East Asia. I successfully supported 20 manufacturing sites across the Asia Pacific region in implementing computer systems validation aspects of the GSK Quality Management System.Prior to my assignment in Kuala Lumpur with GSK, I spent 6.5 years at the Boronia GSK site in Melbourne, where I gained invaluable expertise in validating aseptic process filling, OSD manufacturing, and packaging systems across various technological platforms.My core competencies encompass Computerised Systems Validation, GMP compliance, project management, facility validation, and data integrity. Over the years, I have cultivated strong relationships with regulatory authorities such as the FDA, MHRA, EMA, PDMA, HSA, and TGA, ensuring compliance with their stringent requirements.