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Hannochyehuda Qam Resume
Hannochyehuda Qam Resume
Hannochyehuda Qam Resume
CAREER HISTORY
Dexcel Pharma, Israel – CGMP Compliance Manager
2008
Dexcel is a research-based private pharmaceutical company manufacturing controlled release
oral solid dosage form drug delivery technologies. Dexcel is presently active in 18 countries and
maintains operations in Israel, United Kingdom, Germany and USA.
Responsible for all Quality Assurance and cGMP Compliance requirements for three facilities
that included building a new dry production facility in Israel.
Responsible for the QA and cGMP activities in United Kingdom and Germany.
Directed and conducted internal (all departments within the company) and external audits
(Active and Inactive raw material manufacturers) and followed up to confirm completion of
any deficiencies noted during audits.
Coordinated in house training programs and trained employees from the QA, production and
maintenance departments.
Handled customer complaints and deviation reports including out of specifications by
investigating into the root cause and suggesting corrective and preventive actions where
required.
Managed internal and external suppliers by confirming that they worked according to cGMP
and predefined SOP's.
Responsible for change controls, corrective and preventive actions, technical/quality
agreements, annual product reviews, training, leading quality improvement processes.
Ensured timely release of products while assuring product quality and full compliance.
Led various Quality Assurance projects as well as actively participated in various other
projects.
Approved process validation reports and validation reports of system/equipment/cleaning/ IT
systems.
Led Dexcel in all inspections and Quality Audits of FDA, MHRA, EMEA, Ministry of Health in
Israel and by various companies that included STADA, Perigo.
LUDAN Engineering, Israel – Validation & Quality Assurance Consultant
2007-2008
LUDAN Engineering Co. Ltd. serves process industries and has acquired expertise in project
validations implementation and consultations for: pharmaceutical/ biotechnology and food/
beverage.
Consulted various pharmaceutical and biotechnology companies in building new sites or
extensions according to cGMP compliance.
Guided various pharmaceutical and biotechnology companies, to write various SOP’s, working
instructions, equipment, cleaning and process validation protocols and reports.
Prepared various pharmaceutical and biotechnology companies for quality audits.
Actively participated in various projects.
EDUCATION
Bachelor of Science Degree, Specializing in Chemistry
1983-1986
CQM (Certified Quality Manager)
2000-2001
PROFESSIONAL DEVELOPMENT/TRAINING (AMSTERDAM/ISRAEL)
Conducting Effective Quality Certified Instructor/Trainer of
Audits cGMP, SOP’s
Water Systems- Management Courses:
Pharmaceutical Industry Leadership Development
Granulation, Tabletting, Recruiting and Hiring
Capsulation People and Performance Management
SOP writing from Signet Time Management
AWARDS
Received the best workers award for the year 2000 from the President of Israel.
Received the Star Award for achieving the top (No.1) position in sales of Tenormin
for ICI.
Received the Star Award for achieving the top (No.1) position in sales for Glaxo.
TECHNICAL/COMPUTER SKILLS
SQLLIMS - for the labs. QAITS - Quality Assurance Investigation
Link Works - authorized documents Tracking System (TEVA) Project Leader on
GX Pharma - authorized documents behalf of Teva Israel
Wisdom- authorized documents Unichamps - Maintenance & Production
Infosite - Teva’s Global program ERP - Warehouse & Production
Bosanova - Logistics Excel, Word, PowerPoint, Internet & e-mail
Quality System - Quality Assurance