Consultant, Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: United Kingdom

Rob Hughes has worked in the pharmaceutical industry for 30 years. He supports organizations in systems development and implementation, mentoring, staff development, training and process mapping.

Mr. Hughes began his career in tablet analysis and supplier assurance at Glaxo, where he underwent training as a Qualified Person. He subsequently joined ICI (later Zeneca) as Quality Assurance Officer responsible for tablet manufacturing at Macclesfield. Later he had responsibility for the quality assurance of liquids and creams and management of the product release office. After leading a project to prepare for the first FDA inspection of API manufacture at Macclesfield, he was seconded to the Bristol API plant as Quality Assurance Manager.

Mr. Hughes then moved to Central Operations QA initially with responsibilities for the development of QA systems for the international supply chain and the management of post approval dossiers, and subsequently the development and implementation of the international QA strategy and supporting systems.  During the merger with Astra, Rob was responsible for devising the structure of QA in operations and development. Post merger he assumed responsibility for the development of the corporate quality management system and the strategy for process analytical technology.

After transferring to R&D as Head of QA for drug substance and drug product development, he assumed leadership of the continuous improvement team responsible for improving R&D performance from pre-clinical to the end of Phase II. During this period, he worked with industry colleagues to produce a lifecycle guide to change management under the ISPE PQLI initiative.

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