John Coombs
Engineering Compliance Specialist @诺华
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WORK HISTORY
Engineering Compliance Specialist @诺华
Basel, CH
Development and implementation of engineering compliance documentation, covering a diverse range of engineering disciplines. Technical Guidance Documents, Quality Directives and SOP\'s.
EDUCATION
Distance Learning
M.Sc., Engineering Validation
University of Reading
Physics
Nottingham Trent University
Organic Chemistry
Aveta Solutions
Certified Green Belt, Lean Six-Sigma
University of Durham
Applied Mathematics
ABOUT JOHN COOMBS
QA - Validation and Qualification Manager for a wide variety of MultiM$ Pharmaceutical and Biotechnology Projects for major pharmaceutical manufacturers and contractors. Highly mobile and have worked in many different countries and environments within Europe, Asia and US. Clients include sanofi pasteur, Merck Sharp and Dhome, Schering Plough, IHI Takeda, GSK, J&J/Crucell, Abbott Laboratories, Pharmadule, Jacobs Engineering Group, Project Management Group. Thriving on initiation of project teams and systems to deliver the qualification and validation requirements of the project. Specialties: FDA and EMEA regulations. GXP. Member of ISPE, currently working on Periodic Review/Re-qualification task team. Active COP member for C&Q, HVAC, Project Management, GAMP, Engineering Standards Benchmarking, QA.
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