Fionnuala Burke

Fionnuala Burke

Quality and Compliance Consultant

Fionnuala is an Industrial Microbiologist and Qualified Person with over 24 years experience in all aspects of Quality Control and Quality Assurance. In her early career she spent 13 years with LEO Pharma in Dublin and as QA Compliance Manager facilitated Japanese, EU and US regulatory inspections.  With a strong background in manufacturing operations, including aseptic manufacture and topical, filling & packaging, she co-ordinated many of the technical functions as the Site GMP Training Manager.

Fionnuala established her own consultancy undertaking a breadth of Quality and Validation roles including preparing US multinational pharmaceutical companies for FDA inspections and approvals for manufacturing and marketing of medicinal products.  These have included approvals for sterile, high value products.