Hannochyehuda Qam Resume

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HANNOCH YEHUDA

14, Mountbatten Road, Thornhill, Ontario, L4J 8A5


hannochyehuda@gmail.com,
Cell No.: 647-929-3073

Quality Assurance Manager


Dynamic Leadership combined with Professional Experience
OBJECTIVE
To achieve a challenging position where my experience and interpersonal skills can contribute to
the success of the company.
CAREER PROFILE
Dynamic Quality Assurance Manager with extensive experience in the pharmaceutical industry.
Demonstrated ability to turn around underperforming operations and achieve unprecedented
results. Top performer with a career long record of professionalism. Recipient of several
achievement awards. Mature team player with excellent communication in English, can speak
Hebrew and Indian languages as well.
Demonstrated Achievements in:
 Strategic Vision and Planning  Relationship Management

 Leadership and Team Building  New Product Launches

 Executive Presentation  Change Management

 Conflict Management  Quality Audits

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.

Teva Pharmaceuticals Israel – Quality Assurance Manager


1995-2007
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the
development, production and marketing of generic and proprietary branded pharmaceuticals as
well as active pharmaceutical ingredients. Teva is among the top 20 pharmaceutical companies
and among largest generic pharmaceutical companies in the world. (Please note that Novopharm
is a part of Teva).
 Responsible for Quality Assurance of the formulations department (including R&D) at Kfar
Saba Israel.
 Responsible for annual product reviews, ANDA’s, change controls, corrective and preventive
actions, internal and external audits, quality agreements, training, leading quality
improvement processes.
 Handled customer complaints and deviation reports.
 Conducted internal (all departments within the company) and external audits (Active and
Inactive raw material manufacturers).
 Approved process validation reports and validation reports of system/ equipment/cleaning/ IT
systems.
 Released product and packaging files.
 Wrote SOP’s, work instructions, test instructions, validation protocols etc.
 Led various Quality Assurance projects as well as actively participated in various other
projects.
 Reported about QA activities to QA Global Unit.
 Actively involved in all inspections by FDA, MHRA, Ministry of Health of Israel, Brazil, Hungary
and by various companies that included Pfizer, Merck, and Perigo.
ADDED PROFESIONAL EXPERIENCE
ICI Pharmaceuticals – Area Sales Manager
1989-1994
 Responsible for the sales of the pharmaceutical products in the whole western region of India
and responsible of six Regional Sales Managers who in turn were responsible of six to seven
medical sales representatives each.
 Responsible for forecasting sales targets and strategies to achieve them.
 Training representatives and team leaders about product information and handling conflicts.
Glaxo Pharmaceuticals Ltd. – Regional Sales Manager
1987-1989
 Responsible for the sales of the pharmaceutical products in the whole Maharashtra state and
responsible of seven medical sales representatives.
 Training new representatives in the field.
 Successful in obtaining outstanding hospital orders by creating good relationships with key
personnel.
PCI Ltd. – Medical Representative
1986-1987
 Responsible for the sales of the pharmaceutical products in Bombay.

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

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