Jose (Yossi) Chvaicer, M.Sc.
Senior Validation and Quality Project Manager
Mr. Jose Chvaicer graduated in Mechanical Engineering from the State University of Rio de Janeiro, Brazil, and he has a Master’s Degree in Industrial and Management Eng. from the Technion – Israel Institute of Technology, Haifa, Israel. Jose holds a lead auditor certificate from the IIS (ISO9001, ISO13458).
He has over 25 years of international experience in the Pharmaceutical Industry. While being an expert in Validation of equipment and utilities (DQ/IQ/OQ/PQ) he has a rich background managing large scale engineering projects in cGMP environments including design, building and commissioning of production plants, manufacturing and packaging lines, analytical laboratories and warehouses. Yossi is also an expert in leading certification projects on pre-inspections for utilities and equipment for manufacturing finish products (API’s, OSD and Biotech plants) including Autoclaves, Purified Water and HVAC systems. He has conducted FAT’s worldwide and has created and applied an innovative model for Design Qualification (DQ) which reduces costs while meeting quality requirements. More recently, Yossi has managed Compliance and Validation complex projects in the Medical Device industry. Yossi, a Six Sigma Green Belt, brings extensive experience in quality audits (Israeli MoH, FDA and EMA) and in leading multidisciplinary improvement teams for production processes and organization support for Process Validation. He is highly motivated for team work and for leading quality and engineering projects.
During his work at Gsap Jose led Projects for the following companies: Inpack, Periclas, Yam Hamelah, Kalia, Perigo, Pluristem, Stem Cell Lab, Bioforum, Data, Accelta, Philips, Arineta, MedyMatch, NSR and PCB.