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Temporary Manager, Consulting and Trainer about Quality Assurance, Statistical Analysis of Manufacturing Process (Quality Assurance, Quality by Design, Risk Management, Deviation handling, Process and Cleaning Validation, CPV, Minitab), Revamping and Start-up of new plant and facility, New product introduction and Audit
Ing. Caterina De Carlo
Graduated in Chemical Engineering and specialized with a Master in Pharmaceutical Technology
I have been working for several pharmaceutical companies, marketing authorization holder, contract manufacturing and consulting, reaching a strong knowhow in quality assurance and technical operation mostly for drugs but also for medical devices and cosmetics, experience in statistical analysis applied to the manufacturing process (oral solid, soft-gel, sterile liquid and lyophilized) using Lean and statistical tools such us Lean Six Sigma and Minitab®. Team and Project Management experience has been gained, working as validation team manager for new product introduction, plant revamping and start-up, audit management.
Trainer freelance at education centers for characterization and statistical analysis of manufacturing process (Quality by Design, Risk Analysis according to ICH, Process Validation, CPV, Minitab).