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Objective Pleasure to submit my CV hoping to share with you my experience for about
Industry at Quality Assurance; I hope to be a member of your exclusive staff in your esteemed Company.
Education
2006 Bachelor of Science
Alexandria University, Egypt
Chemistry & physics
Grade: Good
Skills Personal Skills
• Good Communication
• Good problem solving
• A hard worker and appreciate team work being productive is my aim as I have
analytical and integrated abilities, dealing with people on a quite satisfactory
level.
• Ability to work independently or as part of a team.
• Listening, Negotiating and
Computer Skills
• Windows ( XP
• Microsoft office Package (Excel, Word. PowerPoint)
• Internet search
Languages
Arabic: Mother Tongue
English: Very Good (Written and spoken)
Professional ExperienceOctober 2016
till present
I work as a Assistant QA Manager
(EEPI).
2012 – 2016 Worked as a Section Head
ISLAM HAMDY MEHAWED
Page 1 of 4
Pleasure to submit my CV hoping to share with you my experience for about 10
Industry at Quality Assurance; I hope to be a member of your exclusive staff in your esteemed Company.
r of Science
University, Egypt
Chemistry & physics Department
Good Communication and Leadership Skills
problem solving skills and ability to learn new tasks
A hard worker and appreciate team work being productive is my aim as I have
analytical and integrated abilities, dealing with people on a quite satisfactory
Ability to work independently or as part of a team.
Listening, Negotiating and persuading skills.
Windows ( XP – Vista – win 7 )
Microsoft office Package (Excel, Word. PowerPoint)
Internet search
Mother Tongue
Very Good (Written and spoken)
Experience
a Assistant QA Manager at European Egyptian Pharmaceutical Industry
a Section Head at European Egyptian Pharmaceutical Industry (EEPI).
ISLAM HAMDY MEHAWED
Alexandria, Egypt
00201009743779 - 002035926141
10 years in Pharmaceutical
Industry at Quality Assurance; I hope to be a member of your exclusive staff in your esteemed Company.
skills and ability to learn new tasks
A hard worker and appreciate team work being productive is my aim as I have
analytical and integrated abilities, dealing with people on a quite satisfactory
at European Egyptian Pharmaceutical Industry
at European Egyptian Pharmaceutical Industry (EEPI).
035926141
Islam Hamdy Mehawed – Resume
Page 2 of 4
2007 – 2012 Worked as a Specialist at European Egyptian Pharmaceutical Industry (EEPI).
2006 – 2007
Worked as a Team Leader in T.V.B Marketing international company
(Tourist Company) for 11 Months.
Responsibilities As a Assistant
Quality Assurance
Manager
• Responsible for cGMP compliance team for daily inspection and follow up
manufacturing areas.
• Responsible of QMS documentation : -
- Deviation and quality defect investigation.
- Change control system.
- NCR/CAPA System and follow up.
- Internal audit program.
- Complaints and Recall.
• Responsible of Supplier qualification program.
• Responsible of execution committee. (Raw materials, Packaging Materials,
Finished Products and Chemicals).
• Responsible of MSDS issuing and distribution.
Job description • Assist Quality Assurance Director in all aspects of Supervision of GMP
department and employees.
• Supervise QA team who carry out the detailed assessment of products and their
components at different stages of production.
• Participate in establishment of the objectives of QA directory and according to
these objectives, I define the needs, expectations and resources to determine the
finally budgets for the department.
• Review all SOP(s) before approval from QA director to assure the compliance of
all directories with GMP regulations and QMS to be on risky based.
• Evaluate CAPA responses to the assessment findings for adequacy, including root
cause and timelines.
• Participate in preparing the company for external audits from WHO, EUROPEAN
• COMMISSIN (Romania MOH) and MHRA, as member in the team which guided
the Auditors in the audit program.
• Ensure compliance with current Good manufacturing practices (cGMP) around
the entire facility, Company standard Operating Procedures (SOPs), Good
laboratory Practices (GLP), Good Storage Practices (GSP), Good Documentation
• Perform an internal audit related to (GMPc, QMS, EMS and OHSAS) systems on all
departments in plant. (Production, QC labs, R&D, Utilities, Warehouses and
distribution warehouses).
• Assure compliance with cGMP, Environmental & Safety Rules , Elements of ISO
14001 & ISO 18001 standards around the facility.
• As a member in QRM committee.
• As a member in Safety and Occupational health committee.
Islam Hamdy Mehawed – Resume
Page 3 of 4
Job description (Cont.) Qualification System
• Attend in all qualification processes for equipments, HVAC system and Water
treatment station and make sure that the annual calibration plan for all
equipments, devices and balances performed.
• Review and approve documentation of qualification (IQ, OQ.PQ) of new
equipment, facilities, and critical utilities including FAT and URS document.
Validation System • I have a lot of knowledge about the process & cleaning validation and I know the
main items of the validation protocols and reports but I didn’t participate in the
issue of validation protocols and reports because, we have a separate validation
department in our QA directory.
• As a member in Validation committee.
• Currently, I make online follow up of validation batches and contribute in
determination of equipment sampling plan during cleaning validation study
inside the production areas through my team.
Vendor Qualification System:
• Define all of our vendors ( Raw material, Packaging material, Gases and
outsourcing services ) in collaboration with planning directory.
• Classification of our vendors according to our specification and switch role (
General, Approved & Certified ) in collaboration with QC directory.
• Issue of vendor qualification plan for approved and certified vendors only
• Evaluate of vendors responses on the audit by mail in case of Raw materials
vendors.
• Make the audit by visit after the compliance of the vendor’s responses with
regulation and our specification.
• Conduct all audits by visit for all vendors as a lead auditor.
• Participation in Vendor Audits and evaluation of suppliers ( Raw and Packaging
Materials ) as a team leader.
Training System:
• Determine the training needs in the first of year for all employee(s).
• Issuing the training plan.
• Evaluation of all employee(s) before and after conducting the training programs
to determine the effectiveness of training on their performance.
• Participate in the training programs in our company as a GMP trainer.
• Train the QA (GMP team), and provide them with the documented quality
standards as guidelines for their day-to-day work.
Islam Hamdy Mehawed – Resume
Page 4 of 4
Professional Certified Training Courses
• GMP professional course (From Charisma quality center).
• Certified as a Lead Auditor for ISO9001:2008 from IRCA.
• ISO 9001:2015 awareness (Arab Academy for Science & Technology)
• Clean rooms and HVAC system.
• Handling of Out Of Specs ( OOS ) and Out Of Trend ( OOT )
• Team Building & Soft Skills.
• Risk management system ( ICH Q9 ) in pharmaceutical industry.
• Quality management system ( ICH Q10 )
• Vendor & Contract Pharmaceutical Supplier Qualification and supply chain.
• Change Control.
• Health & Safety and How to Deal With Chemicals and equipments.
• GSP (Good Storage Practice).
• Process validation and cleaning validation.
• WHO Requirement.
• Pharmacovigilance.
• ISO 13485 for ( Medical Devices ).
• Training of trainer (T.O.T).
• Problem solving and decision making.
• Conversational English Diploma-Elementary.
Personal Information
• Date of Birth: May , 15 1984
• Nationality: Egyptian
• Marital Status: Married.
• Military Status: Exempted.
Hoping to receive your positive reply enabling me to serve your esteemed
Company and It will be a great honor to be one of your staff.
References Furnished upon Request.
