Basic Info

Hadeer Abdelhameed

4 years

El giza, Egypt

Bachelor's Degree

Experienced

Work Experience

Regulatory Affairs Specialistt at Ameco technology for medical industry

Experience Details

Regulatory Affairs Specialistt

Medical/Healthcare

Experienced (Non-Manager)

•Coordinate efforts associated with the preparation of regulatory documents or submissions.
•Coordinate, prepare, or review regulatory submissions for domestic or international projects.
•Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
•Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
•Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Compile and maintain regulatory documentation databases or systems
•Recommend changes to company procedures in response to changes in regulations or standards.
•Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
•Prepare or maintain technical files as necessary to obtain and sustain product approval.
•Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
•Write or update standard operating procedures, work instructions, or policies.
•Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
•Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
•Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
•Participate in internal or external audits.
•Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
•Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
•Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
•Develop or track quality metrics.
•Coordinate recall or market withdrawal activities as necessary.
•Handling and investigate customer complaints.
•Analyze the customer complaints every quarter and at the end of the year.
•Analyze product complaints and make recommendations regarding their reportability
•Notify CEO, GM and the appropriate departments about this analysis.
•Determine the need for remedial action, response to the customer by the required actions or communicate with the proper person in our company to take this action.
•Review the risk management file for every customer complaint.


Company Details

Ameco technology for medical industry

Egypt

N/A

Medical Devices and Supplies

N/A

Nov 2016 to present (8 months)
Quality Control Specialist at Mamiba for hotels supplied

Experience Details

Quality Control Specialist

Quality

Entry Level

•Oversee production and quality control
•Test quality of raw materials and finished goods.
•Send raw materials and finished goods to laboratory for testing and required follow ups
•Guide and handle a team for processes and implementation of GMP like production, filling and packing.
•Maintenance of machinery and equipment in lab.
•Liaison with R&D department to get additional products added to portfolio


Company Details

Mamiba for hotels supplied

Egypt

N/A

Cosmetics

N/A

Jul 2016 to Nov 2016 (4 months)
Senior QC engineer at Safety Road Material Co. Sarmac

Experience Details

Senior QC engineer

Quality, R&D/Science, Analyst/Research

Manager

-Evaluate adequacy,interpret and implement quality assurance standards.
-Devise sampling procedures and directions for recording and reporting quality data.
-Plan, conduct and monitor testing and inspection of raw-materials and products to ensure finished product quality.
-Review the implementation and efficiency of quality and inspection systems.
-Investigate customer complaints and non-conformance issues.
-Develop, implement, communicate and maintain quality plan to achieve the company's quality policy.
-Reduce cost, waste and increase efficiency of the products.
-Responsible for measuring and testing devices calibration.
-Control of non-confirming products and raw-materials.
-Implement tracking and trace-ability for products.
-Analyze data to identify areas for improvement in the quality system.
-Making sure that manufacturing or production processes are met global standards.
-Reviewing customer requirements and making sure they are met.
-Evaluate audit findings and implement appropriate corrective actions.
-Identify training needs and organize training interventions to meet quality standards.
-Assure product ongoing compliance with quality and industry regulatory
requirements.
-Develop, recommend and monitor corrective and preventive actions.
-Document internal audits ,management systems and other quality assurance activities.

















Company Details

Safety Road Material Co. Sarmac

6th of October, Egypt

11-50 employees

Manufacturing, Construction - Industrial Facilities and Infrastructure, Waste Management

N/A

Dec 2012 to Aug 2015 (2 years 8 months)
Quality Control Engineer at Safety Road Material Co. sarmac

Experience Details

Quality Control Engineer

Quality, R&D/Science

Entry Level

-Developing new formulas for road marking thermoplastic paints product with economical manner.
-Responsible for developing products quality .
-Ensure safe operation in area of concern.
-rework final product and Other Processes since it’s out of specification.
-Quality test for raw materials & Final product (Thermoplastic road marking paint - Glass reflective beads) Tests and release.
-Document laboratory works using laboratory worksheets in details.
-Maintain the data archives and samples.


Company Details

Safety Road Material Co. sarmac

6th of October, Egypt

11-50 employees

Manufacturing, Construction - Industrial Facilities and Infrastructure, Waste Management

N/A

Dec 2012 to Dec 2013 (1 year)
Trainee Flavorist (intern) at IFF Egypt

Experience Details

Trainee Flavorist (intern)

R&D/Science

Entry Level

-Assist in applying and creating new products flavors (savory and sweets)
-Member in committee in session of flavors evaluation
-Implement new product`s formula and application.





Company Details

IFF Egypt (multinational)

6th of October, Egypt

N/A

Food and Beverage Production

N/A

Jun 2012 to Oct 2012 (4 months)
QC chemist (intern) at IFF Egypt

Experience Details

QC chemist (intern)

Quality

Student

Aware with all production processes ( Powder & liquid)
and quality analysis of flavors
- Sensory evaluation for
( odor – taste –color )
- Chemical analysis
Moisture
Chloride content
Refractive index
Density
- Microbiology analysis
Total plate count ( TPC )
Yeast &mold; Enterobacteriace
Coli forms
Staff
Salmonella


Company Details

IFF Egypt (multinational)

6th of October, Egypt

51-100 employees

Food and Beverage Production

N/A

Jun 2011 to Oct 2011 (4 months)

Achievements

See Achievements

-Implement tracking and tractability for the products and raw materials
-Calibrate and make annual plan for test all test devices in Lab and production hall.
-Design ITP (inspection test plan ) for raw materials and products.
-Apply ISO 9001:2008 quality management system in the company and got the certification from SGS.
-Research new products.
-Developing quality of the product


-Develop and create standards for raw materials to maintain the quality of the products.
-Develop quality of the products.
-Design new formulas for products in economical way.
-Reduce waste of the products.
-Apply local and global standards like AASHTO M249, BS , EN ,ES and make sure final products specification meet this standards.
-Create methods (in-process inspections) to control the quality of the products.
-Keep lab data archives.





-Work on new projects
-Have a good background in R&D in flavors and fragrances field


-Have a sap knowledge
-Have a good microbiology back ground
-Have a technical analysis background


Education

College Diploma in Analytical Chemistry

Education Details

College Diploma

Analytical Chemistry

Faculty of science Helwan University, Egypt

B / Very Good / 75 - 85%

N/A

N/A

Faculty of science Helwan University
2016 - 2017
Bachelor's Degree in Chemistry and applied chemistry

Education Details

Bachelor's Degree

Chemistry and applied chemistry

Helwan University, Egypt

C / Good / 65 - 75%

-Organic chemistry -Analytical chemistry -Inorganic chemistry -paint industry -ink -paper -cement -steel -textile and dyes -petroleum -fertilizers and pesticides -paper -packaging -waste manegment

N/A

Helwan University
2008 - 2012

Certifications

TOEFL
Feb 2016

Certificate details

TOEFL

Feb 2016

N/A

N/A

N/A

N/A

Training and Courses

ICDL at Helwan universty
Jan 2012

Training/Course Details

ICDL

Jan 2012

Helwan universty

N/A

Quality control analysis Training and R&D (savory and sweet) at IFF Egypt
Oct 2012

Training/Course Details

Quality control analysis Training and R&D (savory and sweet)

Oct 2012

IFF Egypt

N/A

Quality control paint industry at National research center
Apr 2014

Training/Course Details

Quality control paint industry

Apr 2014

National research center

N/A

ISO 9001/2008 at LRSN
Jan 2015

Training/Course Details

ISO 9001/2008

Jan 2015

LRSN

N/A

Strategic planning at EQS
Apr 2015

Training/Course Details

Strategic planning

Apr 2015

EQS

N/A

GMP at TQCSI
Feb 2016

Training/Course Details

GMP

Feb 2016

TQCSI

N/A

HACCP at TQCSI
Mar 2016

Training/Course Details

HACCP

Mar 2016

TQCSI

N/A

Lean six sigma green belt at Six sigma School
Sep 2016

Training/Course Details

Lean six sigma green belt

Sep 2016

Six sigma School

N/A

This profile is fresh!
Last update 16 days ago.

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Profile Skills and Keywords

6 SigmaAnalytical ChemistryBiotechCE MarkChemistry And Applied ChemistryConstruction - Industrial Facilities And InfrastructureCosmeticsCreativeData AnalysisEnglishFire FightingFood And Beverage ProductionGMPHACCPHard WorkerICDLIFF EgyptISOISO 13485ISO 9001/2008InitiativeInternetLeaderLeanLean Six Sigma Green BeltManufacturingMedicalMedical Devices And SuppliesMicrobiologyMicrosoft ExcelMicrosoft PowerPointMicrosoft WordMinitabPeoplePresentation SkillsProblem SolverQC ChemistQuality AssuranceQuality ControlQuality Control Analysis Training And R&D (savory And Sweet)Quality Control EngineerQuality Control Paint IndustryQuality Control SpecialistR&DReadingRegulatory Affairs SpecialisttResearchRisk AnalysisRoot Cause AnalysisSAPScienceSenior QC EngineerSportsStrategic PlanningTOEFLTechnical AnalysisTrainee FlavoristTravelWaste Management

Self-assesed Skills

Languages

English

English

: Fluent

: Advanced

: Advanced

: Advanced

Tools and Technologies

Microsoft Word

Microsoft Word

: Advanced

: High

:

3-5 years

Microsoft Excel

Microsoft Excel

: Advanced

: High

:

3-5 years

Internet

Internet

: Advanced

: Extreme - I love it!

:

3-5 years

Microsoft PowerPoint

Microsoft PowerPoint

: Intermediate

: High

:

3-5 years

Technical Analysis

Technical Analysis

: Intermediate

: High

:

3-5 years

Presentation Skills

Presentation Skills

: Intermediate

: High

:

1-3 years

Quality Assurance

Quality Assurance

: Intermediate

: Extreme - I love it!

:

1-3 years

Quality Control

Quality Control

: Intermediate

: High

:

1-3 years

minitab

minitab

: Intermediate

: High

:

Less than 1 year

SAP

SAP

: Beginner

: Medium

:

Less than 1 year

Fields of Expertise

Technical analysis

Technical analysis

: Advanced

: High

:

1-3 years

GMP

GMP

: Advanced

: Extreme - I love it!

:

1-3 years

Data analysis

Data analysis

: Advanced

: High

:

1-3 years

6 sigma

6 sigma

: Advanced

: High

:

Less than 1 year

Lean six sigma green belt

Lean six sigma green belt

: Advanced

: Extreme - I love it!

:

Less than 1 year

Root Cause Analysis

Root Cause Analysis

: Advanced

: High

:

1-3 years

ISO

ISO

: Intermediate

: High

:

1-3 years

R&D

R&D

: Intermediate

: Extreme - I love it!

:

1-3 years

HACCP

HACCP

: Intermediate

: High

:

Less than 1 year

ISO 13485

ISO 13485

: Intermediate

: High

:

Less than 1 year

CE mark

CE mark

: Intermediate

: Extreme - I love it!

:

Less than 1 year

Lean

Lean

: Intermediate

: High

:

1-3 years

Fire Fighting

Fire Fighting

: Intermediate

: High

:

Less than 1 year

Microbiology

Microbiology

: Beginner

: High

:

Less than 1 year

Risk Analysis

Risk Analysis

: Beginner

: Extreme - I love it!

:

Less than 1 year

Key Skills

Leader, Hard worker, Creative, Initiative, Problem Solver

Online Presence

https://eg.linkedin.com/pub/hadeer-abd-el-hameed/9a/915/ba0

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