MSc qualified Quality Assurance Professional with 19 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. Most recent positions with 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 to ensure inspection readiness for GxP inspections globally.
Presented at many conferences on PV System Inspection Management. Professional with a large global network with CROs, Sponsors, Regulators and Academia on GVP/GCP Audit & Inspection Management. Member of Research Quality Assurance and on the Pharmacovigilance Committee, Healthcare Business Women Association Member and participating in many other external events globally.