Roger Smith

Roger Smith has a track record of middle and senior roles in quality, production and technical support in the pharmaceutical industry. Between 1999 and 2014, this included Operational Quality Management at GSK, Ware followed by Corporate Quality Audit Manager and Quality Audit Director positions. Roger has a B.Sc. (Hons) in Applied Chemistry and a Diploma in Management Studies. He is a Member of the Royal Society of Chemistry and has been a Qualified Person (QP) for many years, named on several MIA and IMP licences. His qualifications also include an OE Green Belt and he has received training in auditing from the Chartered Institute of Internal Auditors. He has presented at ECA conferences for several years on Batch Record Review and published articles in GMP Review on data integrity, product quality reviews, supplier auditing and deviations.

Qualified Person

Roger can demonstrate both effectiveness and diligence in performing the duties of a QP in compliance with Annex 13 and 16 and is currently acting in this capacity for several organisations. Familiar with both Solid Dose and Steriles (terminally sterilised and aseptically prepared), he has maintained CPD through extensive auditing of manufacturing sites on a global basis.

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