לא צויין
לא צויין
לא צויין
****
מלאה
חודש
אבטחת איכות בתחום וולידציות בביוטכנולוגיה
תיכונית, תואר ראשון
עברית
אנגלית
אין פרטים זמינים
אין פרטים זמינים
2003 – 2006: B.SCI in medical biotechnology - Tel Hai College
2001 – 2003: Business Management, Rishon Lezion.
1992 – 1996: High school named after a "Zeev Bistritzky". Full Bagrut Diploma.
ניסיון תעסוקתי
2012-Today: RAFA LABORATORIES LTD. (One of the biggest pharma company in Israel) - International company with special focusing on the pain releases, narcotic and gastro medicines.
• Specialist in managing, leading and executing validations of equipment, facilities & systems for the biotechnology & the pharma industries.
• Writing validation documents as: URS, DQ, IQ, OQ & PQ for all the equipment systems and facilities in the plant such as: Autoclaves, ovens, Filling lines, laboratory equipment and facilities (HVAC's, plant water system, N2 and compressed air systems) in the highest level of assurance under GMP standards.
• Executing the most difficult and complicated initial validations of the newest machine which purchased by the company for routinely production in the highest level of accuracy, responsibility, regulation and guidelines demands (FDA, Annex and the Israeli minister health demands).
• Intensively cooperate with all the departments of the plant such: Microbiology laboratory, Analytical laboratory R&D, Production and especially the quality assurance to guarantee the planning and the execution of the validation programs on schedule.
• Annually writing the validation master plan of the validation plant team.
• Leading in the main project of RAFA: building and transferring RAFA to the new site 9 years ago, included all the initial validations of the utilities control systems with intensive care of the water system validation assembled from :WFI,PW,SW,RO,Distiller and Pure steam generator. The project of the water system validation achieved commendation from the Israeli ministry of health.
• Qualified to operate all the quality assurance systems such as deviation system, Plant SOP's system and training system.
• Qualified to open and escort deviations, discrepancies, investigations and corrective actions from the moment of the detection till the final decision in the closure stage.
• Full qualification in the quality assurance activities in the plant especially within the cleaning production rooms area.(Class A and B)
• Participating in all the inspections of the new plant: The Israeli ministry of health, FDA and the Brazilian ministry of health (Invisa).
• Constant Persistence to improve the validations and assurance activities in the plant.
• Two times excellence factory.
2009 – 2012: BTG (International specialist healthcare company, developing and commercializing products
targeting critical care, growth hormones, infertility and other disorders)
Senior employee of the production and development of the FSH hormone.
• Responsible for promotion and product development to a product that will become the company's flagship.
• Faculty responsible for the QA interface - Work with the QA related anomalies, change control, review of production files, CAPA and ongoing work in bringing the first product to integrate clinical production stages.
• Work under GMP highest level conditions, standing under the FDA reviews and other global health authorities
• Product development from the initial phases to the integration phase as a research assistant.
• Trustee training teams - responsible for the files of the Department at both the individual workers and team training.
• Responsible for writing procedures (SOP) from the product development stage through to production.
• Over 15 years' experience in QA, validation and in production environment and GMP standards.
• A proven ability to successfully lead and promote projects, and handle various crises.
• Experienced in the biotech field and the pharma industry.
• Management capabilities, organizational and marketing,
• Quick understanding of processes and systems.
