Carlo Frate
Responsible Person - Rp Rpi @Genetech Pharmaceuticals Ltd
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WORK HISTORY
Responsible Person - Rp Rpi @Genetech Pharmaceuticals Ltd
Rainham, GB
EDUCATION
University of Portsmouth
Master's degree, Strategic Quality Management, Merit
University of Sunderland
BSc Hons, Chemical and Pharmaceutical Science
ABOUT CARLO FRATE
A highly experienced Quality Management Consultant and Chartered Chemist with a Master’s Degree in Strategic Quality Management and Cogent Gold Standard Responsible Person (RP/RPi) certified, With over twenty-five years’ experience within Quality Management Systems, Quality Assurance and Project Management. Skills include IRCA Lead Auditor, trained to Green Belt in Lean Six Sigma working within Laboratories, Healthcare and Pharmaceutical companies, Environmental and Scientific Research sectors. I have led internal audits/self-inspections and hosted external assessment by MHRA, VMD, UKAS and LRQA, implemented document control systems, ISO 9001 certification and Laboratory Information Systems utilising PRINCE 2 project management methodology. Areas of interest include: Responsible Person GDP functions (Dir. 2013/C 343/01) Responsible Person for import GMP Pharmaceutical Quality Systems management functions (Dir. 2003/94/EC) ISO 9001:2015 implementation Inspection readyness preparation for ISO/GDP/GMP Annual Product Reviews Self Inspections and Vendor/Supplier auditing SOP preparation, review and publication TrackWise Deviation, CAPA, Change Control process development, implementation and training Recruitment and team reorganisation ad development Metrics and Key Performance Indicator development, review and publication Process improvement utilising Lean/Six Sigma methodologies Risk Assessment, review and publication
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