Hannochyehuda Qam Resume

HANNOCH YEHUDA 14, Mountbatten Road, Thornhill, Ontario, L4J 8A5 [email protected], 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 Audits  Water SystemsPharmaceutical Industry  Granulation, Tabletting, Capsulation  SOP writing from Signet

 Certified Instructor/Trainer of cGMP, SOP’s Management Courses:  Leadership Development  Recruiting and Hiring  People and Performance Management  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. Link Works - authorized documents GX Pharma - authorized documents Wisdom- authorized documents Infosite - Teva’s Global program Bosanova - Logistics Quality System - Quality Assurance

QAITS - Quality Assurance Investigation Tracking System (TEVA) Project Leader on behalf of Teva Israel Unichamps - Maintenance & Production ERP - Warehouse & Production Excel, Word, PowerPoint, Internet & e-mail