Basic Info

Ahmed Ragab

11 years

Alexandria, Egypt

Bachelor's Degree

Manager

Work Experience

Quality control Assistant manager at European Egyptian Pharmaceutical Industry

Experience Details

Quality control Assistant manager

Quality

Manager

Responsible for:
• Application of International standards in analysis procedures.
• Supervising Analysis affairs .
• Approval of raw materials for Production use .
• Issuing & application of Standards Operating Procedures (analysis affairs )
• Ensure that testing processes and Raw materials specifications are met & taking corrective & preventive actions whenever needed & managing positive release of Raw materials to production .
• Review and approve daily test results for materials.
• Schedule laboratory teams to ensure timely and accurate laboratory testing.
• Ensures compliance to the set specifications and takes actions upon non compliance.
• Investigates and confirms OOS test results with lab. Analyst according to the approved OOS SOP before reporting to the laboratory manager.
• Validate results and Approve new raw materials, or current materials from new suppliers according to the material approval SOP and the approved specifications.
• Monitors and ensures that laboratories equipment’s calibration plan is fulfilled.
• Plan / Monitor laboratories requirements (Reagents, chemicals, media , tools , equipment ,…) and ensure that they are provided in a timely manner.
• Ensure good storage for raw materials retained samples in a secured proper manner for monitoring , testing and traceability purposes .
• Dealing with awareness with WHO , ICH & FDA , Eudralex ,EMEA , OMCL & ISO 17025 regulations.
• Responsible for Continuous Improvements according to updated International regulations.


Company Details

European Egyptian Pharmaceutical Industry

Alexandria, Egypt

501-1000 employees

Pharmaceuticals

http://www.eepi-pharco.com/

Nov 2014 to present (2 years 1 month)
Analytical &Technical; affairs responsible for ISO 17025 team. at European Egyptian Pharmaceutical Industry

Experience Details

Analytical &Technical; affairs responsible for ISO 17025 team.

Pharmaceutical

Manager

Responsible for :
All ISO technical affairs (raw materials and finished products for 7 rounds):
• Issuing & application of Standards Operating Procedures for all ISO activities
• Supervising analysts work.
• Insuring results reproducibility .
• Uncertainty calculation .
• Participating in Proficiency testing lab. activities.
• Contributing successfully in proficiency testing lab. activities for 5 rounds
( UVanalysis , HPLC analysis , TLC analysis )


Company Details

European Egyptian Pharmaceutical Industry

Alexandria, Egypt, Egypt

501-1000 employees

Pharmaceuticals

http://www.eepi-pharco.com/

Feb 2009 to present (7 years 10 months)
Quality control Senior(Raw materials affairs) at European Egyptian Pharmaceutical Industry

Experience Details

Quality control Senior(Raw materials affairs)

Pharmaceutical

Experienced (Non-Manager)

Responsible for:
• Supervising Analysis affairs .
• Approval of raw materials for Production use .
• Issuing & application of Standards Operating Procedures (analysis affairs )
• Ensure that testing processes and Raw materials specifications are met & taking corrective & preventive actions whenever needed & managing positive release of Raw materials to production .
• Review and approve daily test results for materials.
• Performing Supplier qualification program through audits .


Company Details

European Egyptian Pharmaceutical Industry

Alexandria, Egypt

501-1000 employees

Pharmaceuticals

http://www.eepi-pharco.com/

Oct 2010 to Oct 2014 (4 years)
Quality Control specialist (Raw materials affairs) at European Egyptian Pharmaceutical Industry

Experience Details

Quality Control specialist (Raw materials affairs)

Pharmaceutical

Experienced (Non-Manager)

Responsible for :
• Complete analysis of raw materials against their monographs in pharmacopoeias.
• Dealing with all types pharmacopoeias such as :European , USP, British , International & Japanese ,through all their monographs, procedures, preparations & general chapters.
• Dealing with all kinds of problems in analysis & source of errors , good thinking about them to ensure quality.
• Member of ISO 17025 team of European Egyptian
Pharmaceutical Industry(Pharco Cooperation) (analysis affairs ).
• Applying GLP rules in the lab.
• Dealing with all Chromatographic systems and Techniques .
( TLC ,HPLC , GC )
• Usage, Ordering and Storage of Chemical reference standards .
• Operation and calibration of laboratories instruments and Apparatus;-
Analytical Balances, Muffles , water baths , Ovens , Vaccum ovens, Ph meters , Viscometers , Thermometers , Refractometer , Polarimeter , Electrothermal apparatus Infrared Spectrophotometer , NIR Spectrophotometer, Ultraviolet Spectrophotometer , Potentiometer, Karl Fisher apparatus .
• Preparation, usage & storage of working standards .
• Dealing with all kinds of testing through wet bench technique & applying the following analytical methods:
1- Quantitative & qualitative analysis dealing with:
- Spectrophotometer such as (Shimadzu UV 2450) and (Cary 100Bio ) .
- IR spectrophotometer (Shimadzu FTIR 8200 ).
- NIR spectrophotometer ( Brucker ).
2- Chromatographic analysis dealing with
- HPLC such as :
• HP Agilent 1100 series ( Isocratic & gradient ones )
• Shimadzu .
- TLC technique .
3- Physical analysis dealing with:
- pH meter ( MP230 Mettler Toledo ).
- Balances ( Sartorius & Mettler Toledo )
- Refractometer ( OPTICH ).
- Polarimeter ( ADP220 ).
- Dissolution apparatus ( ERWEKA DT800, Hanson SR8 Plus ).
- Electrothermal apparatus .
- Potentiometer & Karl Fishcer techniques ( Metrohm ) .
- Particle size analyzer ( Mastersizer E 200 , Malvern ).


Company Details

European Egyptian Pharmaceutical Industry

Alexandria, Egypt

501-1000 employees

Pharmaceuticals

http://www.eepi-pharco.com/

Oct 2004 to Sep 2010 (5 years 11 months)

Achievements


May 2011 Supplier qualification program & performing GMP audits for raw materials suppliers through team,(In China(API)...Biocause Ltd.....China associate Ltd....&India;(API)...Dr.Reddy's...Aarti drugs Ltd.....through May 2011). February 2014 Supplier qualification program & performing GMP audits for raw materials suppliers through team,(In Malaysia,Penang island through February 2014- Symbiotica Ltd. API manufacturer). February 2009 ISO 17025 Project (Accredited by EGAC , ISO17025:2005 ) for Assay & Related substances of Ciprofloxacin Hydrochloride(USP)(HPLC). February 2009 ISO 17025 Project (Accredited by EGAC , ISO17025:2005 ) for Assay of Prednisolone Sodium phosphate (European Pharmacop.)(UV). March 2011 ISO 17025 Project (Accredited by EGAC , ISO17025:2005 ) for Related substances of Prednisolone Sodium phosphate (European Pharmacop.)(HPLC).

Education

Pharmacy in Pharmacy

Education Details

Pharmacy

Pharmacy, Pharmaceutical Scienced

Alexandria University, Egypt

B / Very Good / 75 - 85%

N/A

N/A

Alexandria University
1999 - 2004
High School - Thanaweya Amma

High School Details

Thanaweya Amma

Gamal Abd Elnaser

Egypt

1999

A / Excellent / 85 -100%

N/A

Gamal Abd Elnaser
1999

Certifications

TQM
Jun 2015

Certificate details

TQM

Jun 2015

N/A

N/A

N/A

N/A

Certificate details

Certified Six Sigma Green Belt (CSSGB)(DMAIC)

Jan 2016

N/A

http://iqf.org/?page_id=143

AA11796

International Quality Federation (IQF)

N/A

Training and Courses

GMP at EEPI
Apr 2007

Training/Course Details

GMP

Apr 2007

EEPI

N/A

Training/Course Details

Lean Six Sigma Green belt

Nov 2015

Brooklyn Academy

N/A

Training/Course Details

Total quality management

Jun 2015

Brooklyn academy

N/A

This profile is not updated!
Last update more than 2 months ago.

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Profile Skills and Keywords

Analysis AffairsAnalyticalAnalytical &Technical; Affairs Responsible For ISO 17025 Team.ArabicCertified Six Sigma Green Belt (CSSGB)(DMAIC)Continuous ImprovementCreativeEDQM,USP,FDA,WHO,ICH,MHRA & EMEAEnglishGMPInternetLeaderLean Six Sigma Green BeltMicrosoft OfficeMicrosoft WordNew KnowledgeOracleOrganizerPharmaceuticalPharmaceutical SciencedPharmaceuticalsPharmacyQuality AssuranceQuality ControlQuality Control Assistant ManagerQuality Control Senior(Raw Materials Affairs)Quality Control Specialist (Raw Materials Affairs)SelftrainingSix Sigma Green BeltTQMTeam PlayerTotal Quality Management

Self-assesed Skills

Languages

English

English

: Advanced

: Advanced

: Intermediate

: Intermediate

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

Tools and Technologies

Microsoft Word

Microsoft Word

: Advanced

: High

:

More than 7 years

Internet

Internet

: Advanced

: Extreme - I love it!

:

More than 7 years

Microsoft Office

Microsoft Office

: Intermediate

: High

:

5-7 years

Oracle

Oracle

: Intermediate

: High

:

3-5 years

Fields of Expertise

Continuous improvement

Continuous improvement

: Expert

: Extreme - I love it!

:

More than 7 years

Quality Control

Quality Control

: Expert

: Extreme - I love it!

:

More than 7 years

Analysis affairs

Analysis affairs

: Expert

: Extreme - I love it!

:

More than 7 years

EDQM,USP,FDA,WHO,ICH,MHRA & EMEA

EDQM,USP,FDA,WHO,ICH,MHRA & EMEA

: Expert

: Extreme - I love it!

:

More than 7 years

Total quality management

Total quality management

: Advanced

: Extreme - I love it!

:

More than 7 years

Six Sigma green belt

Six Sigma green belt

: Intermediate

: Extreme - I love it!

:

Less than 1 year

Key Skills

Analytical, Leader, Creative, Organizer, Team Player

Online Presence

https://www.linkedin.com/profile/view?id=AAIAAA__a1wB5mu2Lz5uAb1-6RCNJd6I00hG20c&trk=nav_responsive_tab_profile

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