Ana Luísa Simplício

Quality Control Manager / cGMP Analytical Services Unit (ASU)

Biography

I have been working at iBET since 1990 and have served as the Quality Control Manager of the Analytical Services Unit (ASU) since May 2015. I was responsible for setting up the Analytical Laboratory at iBET and for implementing Good Laboratory Practices (GLP, 1992) and Good Manufacturing Practices (GMP, 2013), primarily for Quality Control of conventional and biological investigational medicinal products.

In my current role as Quality Control Manager of ASU, my primary responsibilities include monitoring of quality control activities in strict adherence to the GMP principles; ensuring maintenance of the premises and equipment qualification; authorisation of written procedures and other documents; planning and reporting method validation; approving the results of quality control tests; training of personnel and advocating continual improvement.

I graduated in Chemical Engineering from the Instituto Superior Técnico of the Universidade Técnica de Lisboa. I hold an MSc in Quality Control of Food from the Faculty of Pharmacy at the Universidade de Lisboa and a PhD in Pharmaceutical Chemistry from Trinity College Dublin.

Specialties: Analytical development, method validation, quality control and quality assurance, quality auditing, training of personnel, quality system management, GxP requirements.