1. Tamer Abdelhakam Hamed
2 EL Oroba st. Kornish EL Nile EL Maadi-Cairo-Egypt
Mobile: 0100 546 88 77
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I. Objective;
Looking for a suitable position in a dynamic work environment, which will enable me to apply my
quality inspection and problem solving skills gained through my academic background and work
experience, An accomplished time manager, organizer and administrator capable of introducing and
integrating innovative strategies to ensure maximum performance of high standard and quality, I am
a highly motivated individual and a strong team player with excellent knowledge.
II. Personal Information;
• Date of Birth: May 3, 1982
• Military service: Exempted
• Marital Status: Married.
• Nationality: Egyptian.
III. Education;
• Faculty of Science Al Azhar University
• Bachelor Degree in Science, Chemistry, May, 2004
• Grade: good
IV. Training Courses;
• In (2015): Certified internal auditor training course according to QS regulation is in Part 820 of
Title 21 of the Code of Federal Regulations (CFR), the current Good Manufacturing Practices (GMP)
requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of
the Food, Drug and Cosmetic (FD&C) Act, and "QSIT" GUIDE TO INSPECTIONS OF QUALITY
SYSTEMS.
• In (2015): Certified internal auditor training course according to EN ISO 14971:2012 “Medical
devices — Application of risk management to medical devices”.
• In (2013): Certified internal auditor training course according to BS EN ISO 13485:2012” Medical
devices — Quality management systems — Requirements for regulatory purposes”.
• In (2013): Certified internal auditor training course according to SA 8000: 2008”Social
accountability” standard from LRSN-M Consultant, training division.
• In (2012): Certification scheme for food safety system FSSC 22000 awareness from LRSN-M
Consultant, training division.
• In (2010): Certificate training in QMS ISO 9001:2008 Auditor/Lead auditor course “IRCA” BSI in
Cairo – TUV.
• In (2009): Certified internal auditor training course according to BS OHSAS 18001:2007 from (CDC
– Cairo).
• In (2009): Certified internal auditor training course according to ISO 14001:2004 from (CDC –
Cairo).
• In (2008): Certified internal auditor training course according to ISO 9001:2008 from (CDC – Cairo).
• In (2008): Certified internal auditor training course according to ISO 22000:2005 from (CDC –
Cairo).
NNBB:: RReeffeerreenncceess aarree aavvaaiillaabbllee wwhheenneevveerr rreeqquueesstteedd..

2. Tamer Abdelhakam Hamed
2 EL Oroba st. Kornish EL Nile EL Maadi-Cairo-Egypt
Mobile: 0100 546 88 77
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V. Career Related Experience;
i. Regulatory, compliance and QMS (Quality Management System) Lead Auditor in
ALLMED Middle East for advanced Medical Industries; May 2013 –present.
ALLMED Middle East Profile;
“Design and production of finished medical devices including sterile disposable arterial/venous
blood lines, hollow fiber dialyzer, hollow fiber Hemofilter, Lena-Cart, fistula needles,
infusion/transfusion sets, bicarbonate cartridges, bicarbonate bag, catheters and Hemodialysis
concentrate and production of pharmaceutical products including intravenous solution”
Responsibilities and Duties;
• Manage and responsible for all activities related of internal and external “Customers or
Suppliers” audits.
• Set and conduct the audit plans and process for all activities in the plant.
• Review and measure the efficiency and the performance of the implemented Quality
Management systems.
• Participated in renewal of ISO 9001:2008, ISO 13485:2012, OHSAS 18001:2007, ISO 14001:2004,
CMDCAS and CE according to MDD93/42/EEC.
• Set the corrective and preventive actions plan for all non-conformities (if detected), customer
complaint, and internal or external audit results.
• Perform a training sessions in CAPA (corrective & preventive action) process for all employees.
• Perform a representation for internal or external audit results, control of nonconforming
products results and CAPA results by using various statistical analysis methods like bi chart, bar
chart, parito chart…etc.
• Reporting the quality management system performance and the statues of the corrective and
preventive actions plans to the Quality, Regulatory & Compliance director monthly.
• Preparing for management review meeting and reported minute of meetings.
• Issue the Quality, Regulatory & Compliance and internal audit statistical reports for
Management review meeting.
• Participate in the issuance of the Risk Management file by performing the risk assessment for all
products/Process including setting Risk management plan, FMEA, Quantitative and Qualitative
characteristics of all devices and the Risk Review Report according to BS EN ISO 14971.
• Establishing training system (training plan, evaluation of members, training procedure, and
organizational charts).
• Training of the new joining on QHSE system.
• GMP training and awareness of employees including the hygiene practices.
• Preparing of Risk associated with the responsibilities of job descriptions.
• Participate in the issuance of the quality objectives for all company sectors and their
measurements.
• Review and Update the company policy and objectives.
• Follow up the CAPAs reports statues.
• Supervise the Document control center activity.
• Participate in validation work as member in validation team such as (packaging validation,
process validation).
• Supervise the calibration process for all devices at the plant.

3. Tamer Abdelhakam Hamed
2 EL Oroba st. Kornish EL Nile EL Maadi-Cairo-Egypt
Mobile: 0100 546 88 77
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ii. Quality Assurance Section Head in MGM (Misr Glass Manufacturing) for Glass
manufacturing; February 2008 –April
2013.
MGM Profile;
A production of quality lightweight flint, green and amber glass containers to international
standards for a variety of consumer and pharmaceutical products.
Responsibilities and Duties;
• Participated MGM to be certified in the following standards; ISO 9001:2008, SA 8000:2008, ISO
14001:2004, OHSAS 18001:2007, and ISO 22000:2005 Standards.
• Prepare company internal audit plan on annual basis.
• Manage, maintain and improve quality documentation system.
• Conduct internal audit for all company activities according to applicable standards.
• Submit QMS evaluation report to quality assurance manager on a regular basis.
• Participated in handling of customer complains.
• Making daily audit in chemist laboratories / raw material lab and production lab and making
calibration for each apparatus and gauges to make sure that it is efficiency in high level.
• Monitor closely the implementation of line quality operations, good house keeping, cleaning and
sanitation, validation, complaints and non conformance and corrective and preventive actions.
• Review Product Condition at the various warehouses.
• Work as a Resource to Solve Quality Technical Problems whenever happen.
• Verifying the effectiveness of QMS through System Process Internal Quality Audit.
• Coordinate with Production Engineers SPC and Process Inspection Requirement.
• Ensure the thorough Implementation of the Procedures and working Instructions.
• Develop, writes & updates the Internal Processes and Procedures according to the latest Quality
theories and Realistic Environment Requirements.
• Documenting, Submitting and maintain audit records.
• Responsible of problem solving process and Quality Improvement program.
• MGM became an approved supplier for PepsiCo Egypt and international, Coca Cola Egypt and
International, SAB Miller, Heineken, Nestle, Heinz, Hero, Amoun Pharmaceutical,
GlaxoSmithKline, Sanofi Aventis, Novartis Pharm, October Pharm and El-Hekma
Pharmaceuticals.
iii. Work at SIGMA Company for Pharmaceutical as senior medical representative;
January 2006 – January 2008
• Work as Supervisor Medical Representative to manage and control the activities of the Medical
Representatives.
iv. Work at EGYPHAR Company for Pharmaceutical as senior medical
representative; October 2004 – December 2005
• Work as Senior Medical Representative to manage and control the activities of the Medical
Representatives.

4. Tamer Abdelhakam Hamed
2 EL Oroba st. Kornish EL Nile EL Maadi-Cairo-Egypt
Mobile: 0100 546 88 77
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VI. Abilities and skills;
i. Computer skills:
• Very good dealing with MS office ( word, excel, power point, Visio and project manager
programs)
• Good dealing with the hardware.
• Very good dealing with Internet application.
• Very good dealing with Microsoft Outlook.
• Excellent in using the Internet in Scientific application, Regulation, Applicable Standard and all
relatives to QMS requirements searching.
ii. Languages:
• Arabic: Mother tongue.
• English: very Good.
iii. Personal skills:
• Hard worker, team player, with excellent communication, interpersonal skills.
• Worked independently and collectively with the management to determine methods and
procedures for new assignments.
• Known for great ability to analyze business operations and recommended strategies to improve
performance.
• Established and maintained excellent working and personal relationships with managers,
executives and employees of the company.
• Excellent team-builder & Motivator.
• Have an outgoing disposition that enables communicating with people from diverse
backgrounds, Occupations and cultures.
iv. Reference:
•Eng. Fahmy El Ghazaly “CEO consultant , QHSE Director At Citadel group for Glass manufacturing”
•Chem. Akthm Amer “QHSE Manager At Citadel group for Glass manufacturing”
•Chem. Mamdouh Hassan “Final and Field Quality Leader Olympic Group – Electrolux Egypt”