Biography

Roger Smith
Director

Roger Smith has a strong track record of delivering sustainable performance in Pharmaceutical Quality Assurance and Manufacturing Operations. This draws on his extensive and international experience of leadership in the industry. He has held Middle and Senior Leadership roles with GSK, Norton Healthcare (now part of Teva), Schering-Plough (now part of Merck), Fisons (now part of Sanofi) and Wallis Labs. During the last 15 years with GSK, Roger has been responsible for Operational Quality Management, including acting as a Qualified Person, and more recently within the corporate quality audit function as a manager and director. 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. 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 and published articles on data integrity, product quality reviews, suppliers auditing and deviations in GMP Review.

Qualified Person

The importance of compliance to pharmaceutical GMP and registered processes, to protect patients, company reputation and licences cannot be understated. The role of the EU Qualified Person to certify batches that meet regulatory and quality requirements is a fundamental part of GMP compliance. Roger can demonstrate both effectiveness and diligence in performing the duties of a QP in compliance with Annex 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 and attendance at MHRA conferences and other seminars.

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