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essam lotfy

Lead Auditor

United Technical Services

Location:
Egypt - Cairo
Education:
Bachelor's degree, Biology
Experience:
28 years, 2 months

Work Experience

What's your work experience? Your experience is one of the most important sections in a CV.
List all relevant responsibilities, skills, projects, and achievements against each role.  If you're a fresh grad, you can add any volunteer work or any internship you've done before.
Add Experience

Total Years of Experience:  28 Years, 2 Months   

September 2010 To Present

Lead Auditor

at United Technical Services
Location : Egypt - Cairo
- Represent Slovak certification and notified body no.2265 (3EC International a.s)
- Marketing and sales activities .
- Perform certification audit as per ISO 9001:2008, EN ISO13485:2012, ISO 14001:2004, OHSAS 18001:2007.
- Technical file assessment for the MDD 93/42/EEC
September 2011 To May 2013

QHSE Manger

at HAMAPACK COMPANY
Location : Egypt - Cairo
Employer: HAMAPACK COMPANY.
Packaging company
Job title: QHSE Manger
❖ From September 2011Till Now
Job description: Responsible for: - Develops, in conjunction with the department heads, the policies and monitoring programs, and enforces established policies and regulations.
- Confers regularly with department heads to explore opportunities aiming at improving operations, decreasing turnaround times, streamlining work processes, and working cooperatively and jointly to provide quality seamless products.
- Establish and follow up the implementation of the following management systems.
- Quality Management System according to ISO 9001:2000 family of standards,
- Environmental Management System according to ISO 14000:2004 family of standards.
- Occupational health & Safety Management System according to OHSAS 18001:1999 family of standards.
- Establish monthly healthy, safety and environmental committee.
- Upgrade the plant fire alarm& fire fighting systems.
- Establish a communication channels between departments and each others.
- Improve the quality of the PPE.
- Develops the annual plan for the QHSE programs and directs its implementation.
- Develops and reviews technical and performance specifications, quality levels, sampling plans, and inspections procedures.
- Reviews certificates of compliance and/or test reports to determine validity.
- Investigates complaints of non-conformance and arranges for corrective actions, when applicable.
- Assigns independent internal auditors and supervises their quality review activities.

- Liaises with external Quality Certification auditors for the coordination of quality audits and updates.

- Analyzes statistical test data, writes evaluation reports and suggests corrective actions accordingly.

- Undertakes the planning, following and executing for all programs that has relation with quality, health, safety and environment to create awareness for company employees, customers and subcontractors.

- Set annual materials plan for all HSE equipments.
- Follow setting and executing training plan for HSE programs and determine appropriate levels for each training program.
- Investigate all accidents inside or out side company properties to determine causes and set avoiding recommendations.
- Participate in preparing technical department manpower and training plans in coordination with the Human Resources department.
- Appraises the internal audit team performance regularly and submits results to the
General Manager


Other Work Experience
• CE Mark consultancy for medical device companies, includes preparation of technical files, preparation of quality management system, according to ISO 13485, MDD 93/42/EEC complying system.
• Lead auditor ISO 9001:2008, ISO 13485:2003, MDD 93/42/EEc., for a certification and notified body
• Consultant for the medical devices registrations with the national authority with the preparation of technical files
January 1998 To January 2013

QHSE manager

at NMI
Location : Egypt - Cairo
QHSE MANGER
January 1998 To January 2013

QHSE

at nmi
Location : Egypt - Cairo
QHSE
August 2008 To September 2011

Quality Manager

at National Medical Industries
Location : Egypt - Cairo
QHSE manager
December 2006 To August 2008

Quality Assurance Manager

at E med for industrialization
Location : Egypt - Cairo
Employer: E med for industrialization
Orthopedic Implants company.
Job title: Quality Assurance Manager
❖ From December 2006 till August 2008
Job description: Responsible for:
• Maintain the quality management system for the company.
• Arrange Internal auditing on the company system
• Maintain the requirements of ISO and CE mark requirements.
• Perform the technical files for CE marking
• Maintain the quality certificates ISO 9001: 2008 & ISO 13485:2003 and CE mark (Directive 93/42/EEC)
• Implementing and maintaining the quality standards.
August 2004 To December 2006

Production line manager (non sterile areas-Sterile area)

at Afri Medical company
Location : Egypt
Employer: Afri Medical company (AMC)
Job title: Production line manager (non sterile areas-Sterile area)
❖ From August 2004 to December 2006
Job description: Responsible for: • Establish the production plans for sterile areas according to sales plan and follow
Up achieving of it.
• Determine the man and machines power through production standard outputs.
• Issue the material needs for the production plans
• Plan the production through the sterile areas.
• Analysis the production breaks down and works to prevent its repeat through preventive actions.
• Analysis the failure aspects in the finish product and solve the reasons of it.
• Follow up achieving the production outputs and work to increase it.
• Follow up hygienic control of clean areas
• Perform validation activities for the ETO sterilizer.
• Control waste level of the production lines and minimize it for cost saving.
January 1998 To March 2005

QHSE

at NMI
Location : Egypt - Cairo
QHSE MANGER
September 2002 To August 2004

Team leader of the quality lab

at Unilever Egypt
Location : Egypt
❖ From December 1996 to November 1998
Employer: medical union pharmaceutical company (MUP)
Job title: lab chemist
Job description:
• Chemical analysis for the finished product & raw materials.
• Auditing for the production lines (In process inspection)
• In process inspection on the per weight area &the dispensing of the raw materials
• Quality inspection on lines
• Documentation control
January 1998 To January 2002

production supervisor

at Afri Medical
Location : Egypt - Cairo
Job title: production supervisor
❖ From December 1996 to November 1998

Job description: • Production supervisor for clean areas ( Blood Lines & haemodialysis filter)
• Production supervisor for ETO sterilizer.
• Responsible for achieving production plans and optimum utilization of labor and materials.
• Control the waste level of the raw materials.
• Assure the environmental and hygiene conditions of the clean areas as required.
• Monitoring the sterilization process by ETO gas.
• Perform a validation protocol of ETO sterilizer.
December 1996 To November 1998

lab chemist

at medical union pharmaceutical company
Location : Egypt - Cairo
QHSE manager
December 1996 To November 1998

production supervisor

at Afri Medical company
Location : Egypt
January 1996 To August 1998

Member

at Product Development Committee
Location : Egypt - Cairo
❖ From December 1996 to November 1998
Employer: medical union pharmaceutical company (MUP)
Job title: lab chemist
Job description:
• Chemical analysis for the finished product & raw materials.
• Auditing for the production lines (In process inspection)
• In process inspection on the per weight area &the dispensing of the raw materials
• Quality inspection on lines
• Documentation control


Employer: Afri Medical company (AMC)
Job title: production supervisor
❖ From December 1996 to November 1998

Job description: • Production supervisor for clean areas ( Blood Lines & haemodialysis filter)
• Production supervisor for ETO sterilizer.
• Responsible for achieving production plans and optimum utilization of labor and materials.
• Control the waste level of the raw materials.
• Assure the environmental and hygiene conditions of the clean areas as required.
• Monitoring the sterilization process by ETO gas.
• Perform a validation protocol of ETO sterilizer.


Employer: Unilever Egypt (home and personal care)

Quality inspection on lines

at Documentation
❖ From December 1996 to November 1998
Employer: medical union pharmaceutical company (MUP)

lab chemist

at Afri Medical company
Location : Egypt
Job title: lab chemist
Job description:
• Chemical analysis for the finished product & raw materials.
• Auditing for the production lines (In process inspection)
• In process inspection on the per weight area &the dispensing of the raw materials
• Quality inspection on lines
• Documentation control

Production supervisor for clean areas

at Blood Lines
❖ From December 1996 to November 1998
Employer: medical union pharmaceutical company (MUP)
Job title: lab chemist
Job description:
• Chemical analysis for the finished product & raw materials.
• Auditing for the production lines (In process inspection)
• In process inspection on the per weight area &the dispensing of the raw materials
• Quality inspection on lines
• Documentation control


Employer: Afri Medical company (AMC)

Team leader of the quality lab

at Afri Medical company
Location : Egypt
Employer: Afri Medical company (AMC)
Job title: production supervisor
❖ From December 1996 to November 1998

Job description: • Production supervisor for clean areas ( Blood Lines & haemodialysis filter)
• Production supervisor for ETO sterilizer.
• Responsible for achieving production plans and optimum utilization of labor and materials.
• Control the waste level of the raw materials.
• Assure the environmental and hygiene conditions of the clean areas as required.
• Monitoring the sterilization process by ETO gas.
• Perform a validation protocol of ETO sterilizer.


Employer: Unilever Egypt (home and personal care)
Job title: Team leader of the quality lab.
❖ From September 2002 To August 2004

Job description: • Analysis of raw materials & finished good in lab.
• Member in team of inspection of the packing materials
• Responsibility for holding or releasing raw & finished product
• Member in HACCP team
• Member in cost analysis team.
• Quality inspection on lines
• Documentation control
• Internal cleaning audit for factory
• Responsibility of equipment calibration in lab
• Responsibility of supplier evaluation.
• Responsibility of safety in lab.

Team leader of the quality lab

at Physical and Chemical Laboratory
Location : India
Job title: Team leader of the quality lab.
❖ From September 2002 To August 2004

Job description: • Analysis of raw materials & finished good in lab.
• Member in team of inspection of the packing materials
• Responsibility for holding or releasing raw & finished product
• Member in HACCP team
• Member in cost analysis team.
• Quality inspection on lines
• Documentation control
• Internal cleaning audit for factory
• Responsibility of equipment calibration in lab
• Responsibility of supplier evaluation.
• Responsibility of safety in lab.


Employer: Afri Medical company (AMC)
Job title: Production line manager (non sterile areas-Sterile area)
❖ From August 2004 to December 2006
Job description: Responsible for: • Establish the production plans for sterile areas according to sales plan and follow
Up achieving of it.
• Determine the man and machines power through production standard outputs.
• Issue the material needs for the production plans
• Plan the production through the sterile areas.
• Analysis the production breaks down and works to prevent its repeat through preventive actions.
• Analysis the failure aspects in the finish product and solve the reasons of it.
• Follow up achieving the production outputs and work to increase it.
• Follow up hygienic control of clean areas
• Perform validation activities for the ETO sterilizer.
• Control waste level of the production lines and minimize it for cost saving.


Employer: E med for industrialization
Orthopedic Implants company.
Job title: Quality Assurance Manager
❖ From December 2006 till August 2008
Job description: Responsible for:
• Maintain the quality management system for the company.
• Arrange Internal auditing on the company system
• Maintain the requirements of ISO and CE mark requirements.
• Perform the technical files for CE marking
• Maintain the quality certificates ISO 9001: 2008 & ISO 13485:2003 and CE mark (Directive 93/42/EEC)
• Implementing and maintaining the quality standards.


Employer: National Medical Industries ( NMI)
Medical Devices company.
Job title: Quality Manager
❖ From August 2008 September 2011
Job description: Responsible for:
• Maintain the quality management system for the company.
• Develops, in conjunction with the department heads, the policies and monitoring programs, and enforces established policies and regulations.
• Establish and follow up the implementation of the following management systems: • ISO 9001: 2008 & ISO 13485:2003, OHSAS 18001:2007 and CE mark (Directive 93/42/EEC)
• Arrange Internal auditing on the company system
• Maintain the requirements of ISO and CE mark requirements.
• Perform the technical files for CE marking
• Maintain the quality certificates ISO 9001: 2008 & ISO 13485:2003, OHSAS 18001:2007 and CE mark (Directive 93/42/EEC)
• Implementing and maintaining the quality standards.
• Validation activity performance (Sterilization Process, Clean Room Areas, etc ),
• Non-Conformance analysis and quality cost evaluation,
• Member of the Product Development Committee,
• Quality Control final approvals,
• Microbiological, Physical and Chemical Laboratory supervision,
• Customer Technical Support and Complaints Handling,

Education

What's your educational background?
Let employers know more about your education; remember, be clear and concise.
May 1996

Bachelor's degree, Biology

at Ain shams University
Location : Egypt - Cairo
• B.Sc of science Department of Biology (Biochemistry)
• Faculty of science - Ain shams University
• Grade- Good
• Date of Graduation: May 1996

Specialties & Skills

Lead audit for EN ISO 13485:2012.MDD93/42/EEC

PRODUCTION LINE

SALES PLAN

Lead Auditor ISO 90012008

Lead Auditor EN ISO 134852012

Lead auditor MDD &IVD

Quality Assurance

Software Quality Control

Languages

Do you speak more than one language?
For some jobs, fluency in one or more foreign languages is a plus, so add your language skills to get better results.

Arabic

Expert

English

Expert

French

Expert

Memberships

Are you a member of any organization or professional club?
Your professional memberships provide an informative signal about your career aspirations, so add them!
Organization : in team of inspection of the packing materials
Membership/Role : Member
Member since :
Organization : in HACCP team
Membership/Role : Member
Member since :
Organization : in cost analysis team
Membership/Role : Member
Member since :
Organization : of the Product Development Committee
Membership/Role : Member
Member since :

Training and Certifications

Auditor Training Course As per ISO 17021(Certification Process-Reporting). ( Training )

3EC International
September 2013 (24 hours)

• Lead auditor of quality management system as per ISO9001:2008,EN ISO 13485:2012 And Medical Device ( Training )

3EC International
September 2012 (24 hours)

• Requirements of the medical devices directives and the CE Marking Approach ( Training )

3EC International

• Understanding of the structure of the medical devices directives:93/42/EEC as amended and 98/79/EC ( Training )

3EC International

• Understanding of EU classification of the medical devices . ( Training )

3EC International

• Establishing and understanding of the European CE Marking Approach ( Training )

3EC International

Understanding Risk Assessment,• Value Post Market Surveillance and Vigilance, ( Training )

3EC International

Understanding coming changes to the MDD, IVD ( Training )

3EC International

• Manufacturing Management Certificate by Vienna university of economic and business administration ( Training )

Vienna University

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