לא צויין
נקבה
לא צויין
****
מלאה
חודש
תואר ראשון, תואר שני
עברית
אנגלית
רכב פרטי – רישיון ב'
רכב פרטי
2011-2013 M.A Quality Studies in the Department of Statistics from University of Haifa
2000-2002 B.A in Criminology and Education Department from the Bar-Ilan University in Tel-Aviv
שירות צבאי
Position: Operator of communications systems
ניסיון תעסוקתי
2018- today - QA Manager Fermention Fermentation at Biovac LTD.- Or Akiva
• Establishment of quality system in the Salmonella production department according to GMP requirements.
• Performing corrective and preventive actions, effectiveness tests (CAPA).
• Vendor qualification - Establish a supplier certification system according to regulatory requirements.
• Conducting internal audits and preparations for external audits, including the Israeli Ministry of Health and Israeli & international clients.
• Support different validation processes e.g., compressed air system, steam and HVAC.
• Support the building and implementation of the CIP system.
• Working in an aseptic environment
2013 –2018- Global Innovative R&D at Teva Pharmaceuticals – Netanya, QA Auditor for clinical supplies
• Managed the investigations and corrective action tracking program which include: deviations, OOS investigations, secondary packaging (in coordination with QP for EU countries) for distribution in clinical trials, and CAPAs.
• Review and approval of packaging batch records of clinical supplies conducted by multiple CROs.
• Review and approval of study specific clinical supply plans (packaging, distribution, returns and destruction).
• Preparation, review and Approval of SOPs.
• Interpretation of regulations, regulatory compliance.
• Manage and provide Quality guidance including; building expansion project, batch record review,
product release, packaging, holding, and transfer.
• Developed and assisted in the implementation of the R&D vendor management program for Drug
Product for Clinical Supplies.
• Overseeing of secondary packaging, distribution and clinical supply chain activities in support of
Teva's Global Clinical supply chain unit, in accordance with relevant EMA , FDA and other GMP
requirements.
• Approval and maintained of Quality Technical Agreements
2008-2013
Dexcel Pharma Technologies Ltd.- Or Akiva, Quality Assurance
• Implementation of Quality Assurance systems and Quality regulations in an organization of 1000 employees.
• Writing and updating regulations and working systems in accordance with operational departments.
• Inspecting regulatory process and performing GMP compliance audits in the production and packaging departments to include work in a GMP environment.
• Approving batch files and responsible for releasing batches according to regulations locally and abroad.
• Training employees on regulations based on their job description
• Investigating deviations in products and processes to include, equipment failures and client complaints. Producing corrective and preventive actions and effectiveness tests (CAPA)
• Auditing, approving Annual Products Reviews (APR) for all markets.
• Reviewing and approving validation reports, geometric documents including systems and equipment validations.
• Conducting internal audits and preparations for external audits including FDA, Israel Ministry of Health and clients around the world.
2006-2008
Teva Pharmaceuticals – Kfar Saba, QA Analyst
• Investigating deviations in products and processes to include equipment failures and client complaints. Producing corrective and preventive actions and effectiveness tests (CAPA)
• Inspecting regulatory process and performing GMP compliance audits in the production and packaging departments to include work in a GMP environment
• Experience and knowledge in the quality assurance from pharmaceutical industry.
• Expert in conducting investigations and GMP audits
• High interpersonal communication, highly motivated to learn and results oriented
• Volunteer for youth at risk
