I been with the MHRA since March 2005 as a GMP Inspector. As an Inspector, I have inspected in areas including Sterile Pharmaceutical Manufacturing facilities, non-Sterile Pharmaceutical Manufacturing facilities and biotechnology and is responsible for ensuring that the Companies inspected are compliant with EU GMP. I have also taken part in a number of discussion groups.
I have been involved in a number of technological papers including the current version of the PDA Technical Report No.1 and the UK PHSS papers for non-viable monitoring and Bio contamination control strategies. I am currently the Chair person for the joint EMA and PIC/S working group regarding the potential update to EU GMP Annex 1.
Prior to joining the Agency, I worked in the Pharmaceutical industry for approximately 20 years in positions including Quality Control, Quality Assurance and Production. I have a BSc Honours in Microbiology with Genetics, a Post Graduate Diploma in Industrial Pharmaceutical Science and I am also a Member of the Institute of Biology.