Donna Neilson

Background

About Donna Neilson

A versatile, enthusiastic, hands-on self-starter with significant experience in Quality Management Systems and Regulatory Affairs processes gained within the Pharmaceutical, Medical Device and Cosmetic manufacturing environments. Extensive knowledge and demonstrated application of ISO9001, ISO13485, ISO22716, Medical Device Directive (MDD), Medical Device Regulation (MDR), GMP and GDP. Demonstrated ability to implement and execute quality management systems to achieve and maintain compliance in line with business, corporate and regulatory requirements with an ability to understand processes from start to finish and the drive and determination to lead and influence at all levels. Lead Auditor for ISO/GMP/GDP areas and Responsible Person for Wholesale Distribution of Medicines in accordance with WDA(H) requirements, Human Medicines Regulation 2012, GMP and GDP. Demonstrated experience of Inspection management with FDA, MHRA and Notified Bodies.