פרופיל תעסוקתי:

2014 - QA Director and QP. Entera Bio Ltd. Jerusalem
1. Quality System Foundation for GMP Production in the R&D environment.
2. Quality Agreements preparation and managing.
3. GMP/GDP auditing of API, excipients and final drug products manufacturers in
Israel and abroad.
4. Import permits managing for Drug products, APIs and Excipients.
5. ISO 9001:2015 Annual Certification.
6. QP Release of pilot Batches for Clinical Trials.
7. GDP establishment and shipping vendors’ qualification.
8. Pharmaceutical Technology transfer from R&D small scale to contract
manufacturer sites abroad.
9. Analytical methods transfer between laboratories in Israel and abroad.
2013 - Freelancer for QA/QP/RA Consulting. Consulting Services.
1. Consulting of Israeli drug distributor companies before GMP/GDP MOH audits.
2. Quality Audits of Manufacturing facilities abroad on behalf Israeli importer.
3. Consulting for Quality and Regulatory strategic issues for startup pharmaceutical
and medical devices companies.
4. Consulting for CMC submissions, Analytical and Microbiological Compliance.
5. QP Products Release Services.
6. Lecturer at Pharmaceutical Engineering Department at Azrieli College (course
GMP and Regulations at Pharmaceutical Industry).
2011- 2012 QA Manager and QP. Rafa Pharmaceutical Company. Jerusalem.
Direct involvement in foundation of new plant
1. Managing Activities
• Managing of 18 employees’ Quality Assurance Department
• Professional managing of Analytical QC and Microbiological laboratories
2. Quality and Regulatory Activities
• Preparation and managing of MOH audits for GMP and GDP.
• Release of imported final and bulk drug products and APIs.
• Quality agreements and Risk Assessments.
• GDP set up for company’s exported drug product to EU.
• Preparation for Submissions and Changes in Authorization Files.
• Product Quality Reviews, Quality Audits Managing.
• GMP training for site employees
3. Validation Activities
• Shipping and Process Validation Protocols and Reports Approval.
• Validation Master Plan and Overall Validation Program.
2007- 2011 Omrix - Ethicon a Johnson & Johnson company
Direct involvement in foundation of new plant and scale up
2009-2011 - QP Responsible Pharmacist
• FDA and European inspections preparation and active participation
• Quality system foundation in a new company plant in Jerusalem.
• Involvement in Site Approval Regulatory Submission to MOH.
• Shipping validation studies for exported final products.
• Water system and Environmental Monitoring programs preparation.
• Process and Cleaning Validation. Stability Protocols approval.
2007-2009 – QA Supervisor
• Batch release of plasma derived products for European and USA markets
• Annual regulatory reports for FDA and European authorities.
• Change controls and compliance managing.
• QA Supervision for stability studies in QC department.
• Investigation of production deviations, OOS results. CAPA implementation.
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2001-2007 Analytical Laboratory of Medical Corps. IDF.
2004-2007 - Analytical Laboratory Manager Deputy.
• Analytical Methods Development
• LIMS software implementation
• Stability studies planning and performance for drugs and medical equipment
• Calibration managing for the laboratory equipment
2002- 2004 - Analytical Chemist
• QC analytical work with HPLC, GC-MS, FTIR, Atomic Absorption.

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