Basic Info

Mona Zakaria

More than 15 years

Giza, Egypt

Master's Degree

Manager

Work Experience

Quality Control Manager at Sigmatec Pharmaceutical Industeries

Experience Details

Quality Control Manager

Pharmaceutical, Quality, Manufacturing/Production

Manager

• One of the team leaders responsible for B-Lactam Plant design, start-up and commissioning phases.
• Plan, co-ordinate, and direct quality control activities to be in accordance with established standards of GMP and GLP regulations and guidelines.
• Planning and implementation of QC system designed to ensure continuous production of products consistent with production requirements for all incoming materials and outgoing products.
• Formulate and maintain quality control objectives and coordinate objectives with other directorates.
• Direct and evaluate through intermediate personnel the performance of assigned staff to ensure continuous control over materials, facilities, and products.
• Oversee and support Internal and external audits programs.
• Plan, promote, and organize development and training activities related to product quality and reliability through coaching for personnel performance improvement.
• Investigate customer complaints regarding quality.
• Develop recommendations to improve the quality control system throughout the factory.
• Monitor expenditures of staff, equipment, supplies and other resources to minimize costs.
• Approve changes to Quality Control processes and materials to meet specifications and optimize efficiencies.
• Approve Technical Reports for both raw materials and finished commercialized products.
• Provide data and reports in support of the Quality System Management Review and personnel monitoring programs.
• Approve Document Changes as required.
• Approve annual calibration and preventive maintenance programs.
• Other duties and projects as assigned (e.g; acting as production manager due to previous experience in production in case of leave of absence of the assigned production manager).


Company Details

Sigmatec Pharmaceutical Industeries

6th Of October, Giza, Egypt

More than 1000 employees

Manufacturing, Pharmaceuticals

WWW.Sigma-corp.net

Mar 2010 to present (6 years 10 months)
QC Laboratory Manager & Second Deputy Of QC director at Pharco Pharmaceuticals Company

Experience Details

QC Laboratory Manager & Second Deputy Of QC director

Quality, Pharmaceutical, Project/Program Management

Manager

• Ensures laboratory compliance with GMP regulations and GLP guidelines
• Schedules testing of raw materials, in-process samples, bulk and finished products and stability samples in conformity to standards and approved specifications, and on timelines to meet targets for product release.
• Manages Quality Control Staff to include goal setting, performance appraisals, and professional development.
• Ensures training on new methods, SOPs and other technical requirements is completed for all Quality Control staff.
• Monitors expenditures of staff, equipment and supplies.
• Approves changes to Quality Control and production processes and materials to meet specifications, optimize efficiencies and control costs.
• Reviews results for developmental product testing and finished product testing.
• Provides data and reports in support of the Quarterly Quality Systems Management Review and environmental and personnel monitoring programs.
• Reviews and approves Document Changes as required
• Schedules and Monitors in house instrument calibration and preventive maintenance program
• Other duties and projects as assigned


Company Details

Pharco Pharmaceuticals Company

Alexandria, Egypt

More than 1000 employees

Manufacturing, Pharmaceuticals

N/A

Mar 2003 to Mar 2010 (7 years)
Production Section Head of Liquid Products department at Pharco Pharmaceuticals Company

Experience Details

Production Section Head of Liquid Products department

Operations/Management, Pharmaceutical, Manufacturing/Production

Experienced (Non-Manager)

• Supervising for all activities in Preparation and Filling sections of liquid product department
• Supervises and directs the work force to build and maintain efficient and effective work teams compliant with cGMP Production requirements and processes.
• Coordinates the planning, development and implementation of Production processes to maximize efficient operation; revises or directs revision of above procedures when needed.
• Reports on Production status and contributes to the planning and development of efficient system operations.
• Directs the development and administration of SOPs and training programs for the enhancement of work team skills.
• Enforces all cGMP Regulations, follows all Company Safety Rules and promotes positive Safety Culture.


Company Details

Pharco Pharmaceuticals Company

Alexandria, Egypt

N/A

Manufacturing, Pharmaceuticals

N/A

Apr 1999 to May 2003 (4 years 1 month)
Production Supervisor in Liquid Products department at Pharco Pharmaceuticals Company

Experience Details

Production Supervisor in Liquid Products department

Operations/Management, Pharmaceutical, Manufacturing/Production

Experienced (Non-Manager)

Directly responsible for activities in Preparation and Filling sections of liquid product department


Company Details

Pharco Pharmaceuticals Company

Alexandria, Egypt

N/A

Manufacturing, Pharmaceuticals

N/A

Jun 1996 to Apr 1999 (2 years 10 months)
Production Pharmacist in Liquid Products department at Pharco Pharmaceuticals Company

Experience Details

Production Pharmacist in Liquid Products department

Operations/Management, Pharmaceutical, Manufacturing/Production

Entry Level

Directly responsible for activities in Preparation section of liquid product department


Company Details

Pharco Pharmaceuticals Company

Alexandria, Egypt

N/A

Manufacturing, Pharmaceuticals

N/A

Dec 1994 to Jun 1996 (1 year 6 months)
Production Pharmacist in Ampoule Products department at Pharco Pharmaceuticals Company

Experience Details

Production Pharmacist in Ampoule Products department

Operations/Management, Pharmaceutical, Manufacturing/Production

Entry Level

Directly responsible for activities in filling and inspection section of ampoule products department


Company Details

Pharco Pharmaceuticals Company

Alexandria, Egypt

N/A

Manufacturing, Pharmaceuticals

N/A

Oct 1994 to Dec 1994 (2 months)

Achievements


I have succeeded in designing production Batch records during my work in production and setting a standard method of preparation of the Syrups Production department, have helped in designing Job description criteria for various Jobs in the company, have designed and wrote SOP of production machines. During my work in QC, I have taken the Job of validating analytical methods according to the latest Pharmacopoeias at that time of different products, together with being one of the team members in ISO 17025 certification for the laboratories. In my new job i helped in the start up phase of the new production facility, and in revising the layout and updating it of the laboratory area, in selecting all instruments and laboratory furniture.

Education

MBA in Global Management

Education Details

MBA

Global Management

ESLSCA Business School, Egypt

A / Excellent / 85 -100%

Contemporary management, Accounting

International Business Law, Quantitative Business Analysis, Introduction to Competitive Intelligence,Leadership,HR management, Thesis on effect of decentralization of decision making on performance.

ESLSCA Business School
2013 - 2016
Bsc in Pharmaceuticals

Education Details

Bsc

Pharmaceuticals

Alexandria University, Egypt

A / Excellent / 85 -100%

N/A

N/A

Alexandria University
1989 - 1994
High School - Thanaweya Amma

High School Details

Thanaweya Amma

E.G.C School

Egypt

1989

A / Excellent / 85 -100%

N/A

E.G.C School
1989

Certifications

Certificate details

Certified Six Sigma Green Belt

Dec 2011

N/A

N/A

N/A

American Society for Quality

N/A

Certificate details

Professional Certified Trainer

Mar 2016

N/A

N/A

N/A

AUC - School of Continuing Education

N/A

Certificate details

Certified Manager of Quality/ Organizational Excellence

Oct 2016

N/A

N/A

N/A

American Society for Quality

N/A

Training and Courses

Training/Course Details

14 methods for problem solving and decision making

Jun 1996

Total International Expertise Co.

N/A

Training/Course Details

Understanding GMP

Apr 1999

Pharco Pharmaceuticals

N/A

Training/Course Details

Total Quality mangement

Nov 2002

Pharco Pharmaceuticals

N/A

Training/Course Details

Current GMP

Feb 2003

Pharco Pharmaceuticals

Excellent Grade

Training/Course Details

Elevation of leadership and administration skills

May 2003

Amria Pharmaceutical Industeries

Excellent Grade

Training/Course Details

Purified Water For Pharmaceutical Production

May 2003

Amria Pharmaceutical Industeries

Excellent Grade and First Place Award

Training/Course Details

Process Validation

Dec 2003

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Flow charting as process Improvement tool

Feb 2004

Amria Pharmaceutical Industeries

N/A

Training/Course Details

UV-VIS and NIR Spectrophotometry

May 2005

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Problem Solving and Decision Making

Jul 2005

Arab Academy for Science and Technology

N/A

Training/Course Details

Change Control

Feb 2006

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Power Point

Mar 2006

Amria Pharmaceutical Industeries

Excellent Grade and Second place Award

Training/Course Details

Corrective and Preventive Action

May 2006

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Risk Analysis

May 2006

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Internal Audit - ISO 9001/2000

Jun 2006

Arab Academy for Science and Technology

N/A

Training/Course Details

Sterile Production

Aug 2006

Pharco Corporation

N/A

Training/Course Details

Pharmaceutical Inspection

Jun 2007

Pharco Corporation

N/A

Training/Course Details

Good Storage Practice

Jun 2007

Pharco Corporation

N/A

Training/Course Details

Process Flow Charting

Nov 2007

Pharco Corporation

N/A

Training/Course Details

Certified Reference Materials for Traceability and Uncertainty

Oct 2008

National Institute of Standards

N/A

Training/Course Details

Auditing according to ISO 14001 & OHSAS 18001 systems

Nov 2008

Inspectorate (Egypt) LTD.

N/A

Training/Course Details

Internal Audits according to ISO/IEC 17025:2005 requirements

Jun 2008

Lead Engineering Group

N/A

Training/Course Details

Awareness of ISO/IEC 17025

Mar 2008

Lead Engineering Group

N/A

Training/Course Details

Rheology of Semisolids and Suspensions

Nov 2008

Amria Pharmaceutical Industeries

N/A

Training/Course Details

Pharmaceutical Statistics

Nov 2008

Pharco Pharmaceuticals

N/A

Training/Course Details

Fundamental Principles of Analysis

Feb 2009

Pharco Pharmaceuticals

N/A

Training/Course Details

Validation of Analytical Methods

Jun 2009

Pharco Pharmaceuticals

N/A

Training/Course Details

Stability

Jun 2009

Pharco Pharmaceuticals

N/A

Training/Course Details

Chromatographic Analysis

Sep 2009

Pharco Pharmaceuticals

N/A

Training/Course Details

Sampling

Jul 2009

Pharco Corporation

N/A

Training/Course Details

Computer System Validation

Dec 2009

Pharco Corporation

N/A

Training/Course Details

Capability Studies

Nov 2009

Pharco Corporation

N/A

Training/Course Details

Statistics and Statistical Process Control

Nov 2009

Pharco Corporation

N/A

Training/Course Details

Management of Dynamic People

Aug 2010

International Company for Human Resources and Management Development

N/A

Training/Course Details

International Workshop on Pharmaceutical Technologies

Feb 2012

Future University In Cairo

N/A

Training/Course Details

International Workshop on Tablets and Capsules Formulation

Jan 2016

Future University In Cairo

N/A

Training/Course Details

High Impact Presentation

Mar 2016

Dale Carnegie

N/A

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

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Profile Skills and Keywords

14 Methods For Problem Solving And Decision MakingArabicAuditing According To ISO 14001 & OHSAS 18001 SystemsAwareness Of ISO/IEC 17025Capability StudiesCertified Manager Of Quality/ Organizational ExcellenceCertified Reference Materials For Traceability And UncertaintyCertified Six Sigma Green BeltChange ControlChromatographic AnalysisCommitmentComputer System ValidationCorrective And Preventive ActionCurrent GMPElevation Of Leadership And Administration SkillsEnglishFlow Charting As Process Improvement ToolFrenchFundamental Principles Of AnalysisGlobal ManagementGood Storage PracticeHard WorkHigh Impact PresentationInternal Audit - ISO 9001/2000Internal Audits According To ISO/IEC 17025:2005 RequirementsInternational Workshop On Pharmaceutical TechnologiesInternational Workshop On Tablets And Capsules FormulationInternet ResearchInternet SearchLIMSLeaderMBAManagementManagement Of Dynamic PeopleManufacturingMicrosoft ExcelMicrosoft PowerPointMicrosoft WindowsMicrosoft WordOperationsOrganizerPharmaceuticalPharmaceutical InspectionPharmaceutical StatisticsPharmaceuticalsPlannerPower PointPresenterProblem Solving And Decision MakingProcess Flow ChartingProcess ValidationProductionProduction Pharmacist In Ampoule Products DepartmentProduction Pharmacist In Liquid Products DepartmentProduction Section Head Of Liquid Products DepartmentProduction Supervisor In Liquid Products DepartmentProfessional Certified TrainerProgram ManagementProjectPunctuationPurified Water For Pharmaceutical ProductionQC Laboratory Manager & Second Deputy Of QC DirectorQuality AssuranceQuality ControlQuality Control ManagerRheology Of Semisolids And SuspensionsRisk AnalysisSamplingStabilityStatistics And Statistical Process ControlSterile ProductionTeam PlayerTotal Quality MangementUV-VIS And NIR SpectrophotometryUnderstanding GMPValidation Of Analytical Methods

Self-assesed Skills

Languages

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

English

English

: Fluent

: Fluent

: Fluent

: Fluent

French

French

: Intermediate

: Intermediate

: Beginner

: Beginner

Tools and Technologies

Microsoft Word

Microsoft Word

: Advanced

: High

:

More than 7 years

Microsoft Excel

Microsoft Excel

: Advanced

: High

:

More than 7 years

Microsoft PowerPoint

Microsoft PowerPoint

: Advanced

: High

:

3-5 years

Microsoft Windows

Microsoft Windows

: Advanced

: High

:

More than 7 years

Internet Research

Internet Research

: Advanced

: High

:

3-5 years

Internet Search

Internet Search

: Advanced

: High

:

More than 7 years

LIMS

LIMS

: Advanced

: High

:

5-7 years

Fields of Expertise

Pharmaceuticals

Pharmaceuticals

: Expert

: Extreme - I love it!

:

More than 7 years

Quality Control

Quality Control

: Expert

: Extreme - I love it!

:

More than 7 years

Production

Production

: Advanced

: Extreme - I love it!

:

More than 7 years

Key Skills

Leader, Planner, Presenter, Organizer, Team Player

Online Presence

https://www.linkedin.com/in/dr-mona-zakaria-cssgb-miba-7bbaba36?trk=nav_responsive_tab_profilehttps://www.facebook.com/mona.s.zakaria

Achievement is my goal in life

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