BSc (Hons) in Microbiology with Genetics and Post Graduate Diploma in Industrial Pharmaceutical Science.
Over 35 years of diverse career experience.
Current role: Director of Microbiological Contamination Control.
Responsibilities include project design collaboration with engineering, training, mentoring, Annex 1 implementation guidance, and regulatory agency interactions.
Previous role: MHRA inspector for nearly 14 years.
Duties included worldwide inspections (including joint inspections with regulators like USFDA, TGA, TFDA, and Health Canada) in various technical areas (sterile products, biological products, blood components, plasma).
Chairperson of Inspectorates Compliance Management Team (working with marginally compliant companies).
Part of MHRA’s Inspection Action Group (addressing non-compliant sites).
Involved in inspector training, regulatory guidance document creation (e.g., MHRA’s data integrity guidance, EMA’s water systems guidance, Chair for Annex 1 revision working group), and MHRA blog on VHP fragility.
Supported industry bodies with technical monographs like PDA TR1 and PHSS TM20.
Before MHRA, worked for over 20 years in pharmaceutical industry in various roles, including QA, Validation, and Production Management in both sterile and non-sterile manufacturing facilities.