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Validation specialist and sustainability entrepreneur

Work Experience

Fair Trade and human rights entrepreneur, the Netherlands (2010 – Present)
• Project assistance in Fairfood international supporting Asia advocacy Project Leader located in New Delhi, India
• Organizing events in Amsterdam to support EcoPeace organization in the Middle East
• Support interfaith conferences and trip in the ISS, The Hague
• Building web shop and promotional materials at Lotus Design Shop, Nyingma centre in Amsterdam
• Support and develop fair trade initiatives in Israel and the region

Senior Validation Specialist, Centocor B.V, Leiden, the Netherlands (2003 – 2010)
• Implement high level validation documents governing all validation activities on site
• Responsible for the design and implementation of a validation tracking database
• Apply risk management tools and new approach that resulted in reduction of more than 50% of the work load in maintaining the validated state
• Guiding the development of innovative approach to support cleaning validation practices in multi product facilities
• QA Validation representative in a Corporate team to define Critical Process Parameters (CPP’S) for main products

R&D GMP & Validation manager, Serono Biotech Center, Vevey Switzerland
(1999 – 2002)
• Responsible of implementation appropriate quality level in R&D department
• Project leader of implementation of database for documentation and training for the site
• Coordinate release process of clinical trial batches
• Participate with WW R&D Corp. QA to set up quality level requirements for process development and clinical trials manufacturing campaigns
• Responsible for start-up activities of the R&D facility

Validation Manager, InterPharm Laboratories, Nes Tziyonna, Israel (1987 – 1998)
• Responsible for validation of all system and equipment at InterPharm. Main critical systems were: Water (including WFI), HVAC, autoclaves, ovens, cleaning, computerized systems
• Preparing the site and participate in Canadian, EMEA and FDA successful inspections
• Process team member to build new plant and responsible for start-up and validations
• Pilot Plant Manager for production of material for pre-clinical and clinical trial in small scale bioreactors
• Develop processes in spinners, small and large scale bioreactors for producing recombinant proteins in CHO cells
• Production of interferon with E-Coli in lab scale, from ampoule till the final vial

Education

• Introduction to Strategic Sustainable Development, Blekinge Institute of Technology, Sweden (2010).
• M.Sc. with honors, Biotechnology, Hebrew University of Jerusalem (1990)
Thesis: Physiological parameters affecting siderophore excretion in Pseudomonas putida. The studies and thesis work was in parallel to work at InterPharm, Israel.
Supervisors: Prof. Y. Hadar and Prof. I. Chen
• B.Sc. - Agriculture, Plant Protection Department, Hebrew University of Jerusalem, Israel (1983)
• Many courses on various aspects on GMP, Validation in Bio-pharmaceuticals by PDA, ISPE and more. Training in personal development and team buildings.
• One week seminar - Working with the United Nations organizations – Geneva, 2007

Skills

Quality Assurance, validation, risk management, writing policies and guidelines, GMP, Compliance, planning, monitoring, sustainability,

Languages

Hebrew - mother tounge
English - very good in speaking, reading and writing
Dutch -reasonable in speaking and writing and basic in writing
French - basic in all categories

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