Kath Williams - Quality Assurance Consultant

I’m an Analytical Chemist by training and cut my Pharma teeth working in a New Products laboratory for a large pharmaceutical company performing stability testing, process validation and cleaning validation within a GMP environment. From there, I got the auditing bug and moved into a GMP auditing role, conducting audits of UK manufacturing sites (tablets, liquids/creams and sterile facilities).

From there, I transitioned to the GCP arena and quickly gained experience in conducting a variety of GCP audits (Investigator Sites, Clinical and Analytical Laboratories, CROs, Clinical Study Reports, IVRS/IWRS service providers etc).

In February 2004 I joined the Medicines and Healthcare Products Regulatory Agency (MHRA) as a GCP Inspector and later a Senior GCP Inspector. Here, I was able to fine tune my auditing skills and also gain exposure to working with non-commercial organisations conducting clinical research as well as some joint working with the National Research Ethics Service (NRES).

Back in Pharma in 2008, I established myself in my first QA Management role within a small auditing team who were responsible for all GXP audits within Europe. Here, I was also responsible for the strategic development and management of the EU audit program and the associated budget balancing act. I still managed to keep my hand in with audits too, conducting GCP, GPV, CSV and even some supportive GMP work.

From there, I moved to medium pharma with three main roles: strategic development of the global audit program for GCP/GLP/GPV audits, as well as line management responsibility and QA point contact for one of the largest clinical trials ever conducted by the company (and squeezing in quite a few audits too). In December 2013 I finally took the plunge into the consultancy world…