Lead Auditor
United Technical Services
مجموع سنوات الخبرة :28 years, 4 أشهر
- 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
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
QHSE MANGER
QHSE
QHSE manager
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: 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.
QHSE MANGER
❖ 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
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.
QHSE manager
❖ 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)
❖ 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
❖ 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)
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.
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,
• B.Sc of science Department of Biology (Biochemistry) • Faculty of science - Ain shams University • Grade- Good • Date of Graduation: May 1996
