I have many years of diversified experience in quality assurance management in Europe and Australasia. I have comprehensive experience working to international regulatory standards, including OECD GLP and VICH GCP, plus FDA and EMA. I have extensive experience in the development and maintenance of quality management systems, both in document form and within an electronic QMS. I have worked as part of a large quality management team at a multi-national pharmaceutical company and as the leader of a small QA team at GLP accredited CRO’s in Australia and New Zealand. Although my career has been mainly focused on quality management relating to clinical and non-clinical studies within the animal health sector, I have recently expanded my experience into quality management relating to bioanalytical method validation and sample analysis to support human health clinical research, and toxicology non-clinical studies and more recently into ICH GCP human clinical trials.
Listed skills include Quality System, Quality Management, Animal Health, Quality Control, and 10 others.