MSc qualified Quality Assurance Professional with 20 years of diverse Pharmaceutical Industry experience based in the UK. Broad expertise in different GxPs e.g., GVP, GCP, GMP and GDP. Areas of subject matter expertise include Audits & Inspections, Quality Management System & Pharmacovigilance System. 8 years of Pharmaceutical Manufacturing experience with Eli Lilly. 12 years in R&D Quality at Shire/Takeda.
Managed and hosted MAH, Supervisory Authority & many local PV system inspections (e.g., UK, EU, China, Saudi Arabia, South Africa, Australia). Managing matrix teams across Research and Development with contributions from Technical Operations and Commercial. Current role includes responsibility across Pharmacovigilance System, GCP and GLP.