Edward Fahey

Validation Project Manager @Scitech

Cardiff, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2004 — Present

Validation Project Manager @Scitech

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Guildford, GB

Validation Project Manager within an Engineering Consultancy. Assignments vary from lone Regulatory Consultancy to Managing a full Qualification Team as part of a design and build project. Geographic locations have included the UK, Ireland, Sweden, Norway, Finland, Hungary, Belgium, Netherlands and USA.

EDUCATION

1990 — 1993

Swansea University / Prifysgol Abertawe

Bachelor of Science (B.Sc.), Biochemistry

1993 — 1994

Swansea University / Prifysgol Abertawe

Master of Science (M.Sc.), Chemistry

1997 — 2001

University of Bath

Ph.D., Biochemical Engineer

SKILLS

Quality AssuranceBiotechnologyResearch and Development (R&D)Medical DevicesCapaBiopharmaceuticalsGxpAseptic ProcessingV&VR&DChange ControlCleaning ValidationGampHplcPharmaceutical IndustrySopFdaAnalytical ChemistryVerification and Validation (V&V)Quality ControlGmpCorrective and Preventive Action (Capa)Project ManagementU.s. Food and Drug Administration (Fda)Standard Operating Procedure (Sop)ValidationComputer System ValidationBusiness Development21 Cfr Part 11

ABOUT EDWARD FAHEY

An experienced Validation Project Manager in the GMP Pharmaceutical, Radiopharmaceutical, Biotechnology and Medical Device Manufacturing Industries, who is particularly interested in the integration of commissioning and qualification and the application of the risk based approach to qualification process. During the 20 years plus of managing validation projects I have managed projects that have led to successful applications to the FDA, MHRA and WHO.I combine project management & validation knowledge with 9 years of academic experience that lead to a Ph.D. in Biochemical Engineering, a Chemistry Masters and B.Sc. in Biochemistry.Specialties: Project management, Team leadership, Commissioning, Qualification, Validation, Cleaning Validation, Process Validation, Regulatory Consultancy, GMP Training, Radiopharmaceutical & Biopharmaceutical Manufacture.

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Edward Fahey — Validation Project Manager at Scitech in Cardiff, GB | Unifers