A senior manager with nearly 30 years of Blue Chip pharmaceutical industry management experience in QA, QC, R & D and Production, currently focussed on in-house international consultation for MHRA/FDA approvals. In-depth QA Manager’s experience in primary/secondary API processing, healthcare products and medical devices, with a personal focus on all aspects of validation, now specialising in the implementation of MHRA/FDA compliant Quality Systems for successful-first-time Pre-Approval Inspections. Confident in building and managing PAI Teams as well as day-to-day QA requirements such as SOP review, gap analysis, supplier review/approval/management, FMEA, CAPA review and resolution, complaints, technology transfer/product development, etc… Previous employers include Glaxo, SmithKline Beecham, Eli Lilly and Proctor and Gamble. A detailed current and in-depth awareness of US/EU and ICH cGMP requirements and ISO 9001. Recent deliverables include successf ulimplementation of ful y. l GMP systems and MHRA/FDA approval at several facilities for emerging enterprises in the developing Mediterranian arena. The above attributes are strongly supported by an authoritative bright, international flexible and enquiring personality. Currently pursuing roles in validation/cGMP with rapid-move yet flexibility