Donna is a Quality Consultant based in Northern Ireland with over 22 years of experience in the pharmaceutical industry ranging from Drug Substances to Finished Drug Products across multiple dosage forms including non-sterile, sterile, biological products and ATMPs. She has been an active EU Qualified Person (QP) for over 13 years and is currently named as a QP on several Manufacturing Authorisations in Ireland and the UK. Donna has also acted in the capacity of Responsible Person, Deputy Responsible Person, Responsible Person for Importation and Active Substance Registration, Designated Person.
She is experienced in GxP legislation in Europe, UK, USA, South America, and Asia and specializes in GMP and GDP Quality System Management, Regulatory Inspection Readiness, Auditing, and Training with a specialist area of interest in new product introduction and product launches. Donna spent much of her earlier career working for Almac Group in Senior roles and as a QP supporting the release of clinical and commercial products.
Donna has a BSc (Hons) Biological Sciences degree from the University of Ulster and underwent QP training at NSF Health Sciences in the UK.