Basic Info

Mohamed Weshahy

8 years

Cairo Governorate, Egypt

Bachelor's Degree

Manager

Work Experience

Quality compliance section head at Glaxo Smith Kline-Egypt

Experience Details

Quality compliance section head

Pharmaceutical, Quality

Manager

Responsibilities:
1. Ensure site compliance to MOH, WHO and global company guidelines requirements
2. Site Audit readiness for internal and external audits
3. Enhance compliance culture within the site

Job description:
1. CAPA management : responsible for CAPA cycle starting from agreement on SMART CAPA, follow up for CAPA in place and in use verification ending with challenging CAPA effectiveness
2. Change control management: responsible for change control system implementation, change risk assessment, change team selection, agreement with team for pre and post change actions.
3. Quality agreements process owner: responsible for issuance, maintain and update all quality agreements of site with all other parties ( suppliers , customers , third parties , service providers)
4. Quality Track Wise system : responsible for quality tracking system for all actions raised from ( Change control, deviation ,audit , risk , validation reports , process improvement ) to ensure their effective implementation within planned due dates
5. Internal and external audit : planning , preparation and execution of second level internal audit and preparation for external audit
6. Quality management system : perform gap analysis between local process and procedures against company global guide lines and MOH requirements
7. Quality KPIs improvement: Data collection and trend analysis for quality KPIs to identify the areas for improvement
8. Compliance training program : train site staff for all compliance related topics ( audit readiness, self inspection audit, CAPA system , Change control , QMS , gap analysis)


Company Details

Glaxo Smith Kline-Egypt (multinational)

Giza, Egypt

More than 1000 employees

Pharmaceuticals

www.gsk.com

Aug 2015 to present (1 year 5 months)
Production Supervisor at Glaxo Smith Kline-Egypt

Experience Details

Production Supervisor

Manufacturing/Production

Manager

Job description:
1. production plan achievement
2. supervise and control End to end production process
3. manage production staff resources
4. developing capabilities :set training plans and coaching production operators
5. process safety/quality improvement
6. risk management
7. self inspection audit preparation and execution
8. Corrective actions and preventive actions implementation
9. Change control management for production processes
10. Achieve company goals regarding safety, health and environment


Company Details

Glaxo Smith Kline-Egypt (multinational)

Cairo, Egypt

More than 1000 employees

Pharmaceuticals

www.gsk.com

Jan 2015 to Jul 2015 (6 months)
Senior Validation pharmacist at Glaxo Smith Kline-Egypt

Experience Details

Senior Validation pharmacist

Quality

Experienced (Non-Manager)

Job description:
1. Periodic qualification for sterile production area for environmental control, Media fill simulation, Air system qualification, Tunnel & Autoclave qualifications.
2. Performance qualification/Validation for all production process/machines and periodic review and validation confirmation.
3. Process validation plan control and review.
4. Gap analysis for GSK QMS related to qualification and validation department activities.
5. Cleaning Validation master plan and rationale issuance and review for manufacturing machines and instruments.
6. Site Validation Master Plan formulation.
7. EHS coordinator Validation Department.
Responsibilities:
1. Review current periodic qualification protocols for Lactam sterile area and issue updated protocols, coordinate for qualification execution and issue qualification reports.
2. Issue performance qualification protocols for new process/machine and for any required changes , review results and issue final reports
3. Process validation plan review and update for all lactam products in Giza site , coordinate between all concerned departments , collect data and results and issue final report with recommendations for improvement
4. Coordinate with concerned departments to implement cleaning validation plan , collect data and issue cleaning validation report
5. Contribute in review and update site validation master plan.
6. Deviation handling: Issuance of deviation for any identified systems and qualifications runs and contribution in investigation using root cause analysis
7. CAPA management: Set corrective actions and preventives action plans for deviations, audit points, observation and required action for improvement and follow up for progress
8. Change control system: Contribution in implementation of change control system for any process or equipments in lactam production plan
9. L1/L2 Audit: contribution in performing L1 audit in validation department and L2 audit on other departments, understanding system, identify gaps and contribute in finding appropriate CAPA.


Company Details

Glaxo Smith Kline-Egypt (multinational)

Giza, Egypt

More than 1000 employees

Pharmaceuticals

www.gsk.com

Mar 2014 to Dec 2014 (9 months)
Senior Microbiologist at Glaxo Smith Kline-Egypt

Experience Details

Senior Microbiologist

Quality

Experienced (Non-Manager)

1. Microbiology LAB supplies control and purchasing:
- determine and review the required supplies and specifications
- Consumption rate and safety stock calculation, annual budget for microbiology lab
- Communication with suppliers, procurement Dept., accounting Dept.
- Issuing and handling of purchase orders on ESP, receiving of supplies and add it to stock
- Building and maintaining Archiving system (hard copies, electronic) of all related documents, ex. Price offers, annual contracts, invoices, receiving amounts and dates. For effective control and traceability

2. Managing Section tasks as section head delegate:
Managing daily activities, communication with our customers, supply data for others dept. . . . Ex; release dates, water system results .etc.
3. Training for team members:
Training and qualification for team members especially new members, on GLP, microbiology lab activities, updated SOPs, specific microbiology lab techniques. Coaching and close follow up for improvement.
4. Leading daily accountability board:
Follow up with my team for pending actions and managing the planned and unplanned daily required tasks with coordination with section head
5. Lab equipments purchasing process control and determination of required specifications set maintenance contracts
6. Deviation handling:
Issuance of deviation and contribution in investigation using root cause analysis
7. CAPA management:
Set corrective actions and preventives action plans for deviations, audit points, observation and required action for improvement and follow up for progress
8. Change control system:
Contribution in implementation of change control system for any process or equipment which may have an impact from microbiological point of view
9. Validation:
Contribution in microbiological testing methods validation for sterile and non sterile products, validation of autoclaves, depyrogenation tunnels, lab equipments cleaning validation.


Company Details

Glaxo Smith Kline-Egypt (multinational)

Giza, Egypt

More than 1000 employees

Pharmaceuticals

www.gsk.com

Aug 2012 to Mar 2014 (1 year 7 months)
Microbiologist at Glaxo Smith Kline-Egypt

Experience Details

Microbiologist

Quality

Entry Level

1. Environmental monitoring of sterile and non sterile manufacturing areas (sample preparation, sampling, results, trends)
2. Water system monitoring and qualification (purified water, water for injection, trends)
3. Microbiological assays (antibiotics, vitamins)
4. Microbial count limit test and test for pathogens (raw material, packaging materials, and finished products)
5. Microbiology lab annual budget issuance
6. Lab Supplies purchasing, communication with suppliers and stock control
7. BET testing for sterile products
8. Sterility testing of sterile products
9. Validation of autoclaves, depyrogenation cycles (oven and tunnels)
10. Calibration of lab instruments (water bath, incubators, micropipette, and digital burette)
11. Media fill inspection and growth promotion
12. Trend analysis for water system results and sterile area environmental monitoring results

13. Issuing and periodic review for SOPs, general methods, testing standards and Working instructions.
14. Perform root cause analysis all over the site related to any microbiological risks, and change control panels.


Company Details

Glaxo Smith Kline-Egypt (multinational)

Giza, Egypt

More than 1000 employees

Pharmaceuticals

www.gsk.com

Sep 2009 to Aug 2012 (2 years 11 months)

Achievements


5. Technical terms of supplies electronic system project lead:
Responsible for Implementation of new electronic system for managing technical terms of supplies between GSK site:
a) Communicate and train site and suppliers users for new electronic system
b) Manage transfer of old TTS to new system
c) Issuance of new TTS

6. implementation of CAPA management new electronic system in Giza Site:
Responsible for Implementation of new approach of CAPA process management in Giza Site



1. Microbiology lab upgrade:
a) IQ,PQ,OQ for sterility testing area ( issuing of protocols and execution of qualification/validation programs)
- Air Handling unit (viable and non viable samples for different air quality grades
- LAF units, pass box
- Double door autoclave (PQ and OQ for empty cycles, minimum/maximum load cycles for both porous and solution cycles
b) Qualification and validation of microbiology lab upgrade equipments ( incubators , thermal ovens , spectrophotometer , LAF units )



2. Plan and execute Project for Sterility testing method modification for suspension sterile products:
Target: perform sterility test per year with:
a) Less cost: 25,000 LE. Instead of 95,000 L.E.
b) Less working hours : 22 minutes instead of 85 minutes
c) Power saving: use same amount of power for testing double amounts of samples
d) Easier, faster, less risk procedures
e) Decrease storage area for used tools to ¼ old required area
f) Decrease required glassware to ¼ old required glassware



Education

Bachelor's Degree in pharmaceutical science

Education Details

Bachelor's Degree

pharmaceutical science

Cairo University, Egypt

C / Good / 65 - 75%

N/A

N/A

Cairo University
2002 - 2007
High School - Thanaweya Amma

High School Details

Thanaweya Amma

kawmya language school

Egypt

2002

A / Excellent / 85 -100%

96%

kawmya language school
2002

Certifications

Certificate details

CMQ/OE certified manager of quality and operational excellence

Oct 2014

pass

N/A

N/A

american society of Quality ( ASQ)

N/A

Certificate details

ICDL international computer driving licence

Dec 2007

N/A

N/A

N/A

N/A

IELTS
Oct 2010

Certificate details

IELTS

Oct 2010

7 out of 9

N/A

N/A

N/A

Training and Courses

Training/Course Details

 Leadership edge

Jun 2012

Glaxo Smith kline

N/A

Training/Course Details

 Auditing essentials training

Sep 2014

GSK

N/A

Training/Course Details

aseptic manufacturing workshop

Jun 2013

Glaxo Smith kline - UK

global workshop for all the techniques and technology regarding aseptic manufacturing including sterilization process , environmental monitoring program , aseptic techniques etc

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Last update more than 2 months ago.

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Profile Skills and Keywords

? Auditing Essentials Training? Leadership EdgeAnalyticalArabicAseptic Manufacturing WorkshopCMQ/OE Certified Manager Of Quality And Operational ExcellenceDetails-orientedElectronic Purchasing Software (e-SP)EnglishGlaxo Smith Kline-EgyptHard WorkerICDL International Computer Driving LicenceIELTSITManufacturingMicrobiologistMicrobiology LabMicrosoft ExcelMicrosoft OutlookMicrosoft PowerPointMicrosoft WordOperationsPharmaceuticalPharmaceutical SciencePharmaceuticalsPlaying FootballProblem SolverProductionProduction SupervisorQualityQuality AgreementsQuality AssuranceQuality AuditingQuality Compliance Section HeadQuality ControlQuality ManagementSenior MicrobiologistSenior Validation PharmacistSupportiveTechnologyTrackwiseWorkday ( HR Management System)

Self-assesed Skills

Languages

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

English

English

: Fluent

: Fluent

: Fluent

: Intermediate

Tools and Technologies

Microsoft Word

Microsoft Word

: Advanced

: High

:

5-7 years

Microsoft Excel

Microsoft Excel

: Advanced

: High

:

5-7 years

Microsoft PowerPoint

Microsoft PowerPoint

: Advanced

: High

:

3-5 years

Microsoft Outlook

Microsoft Outlook

: Advanced

: High

:

5-7 years

trackwise

trackwise

: Advanced

: Medium

:

1-3 years

workday ( HR management system)

workday ( HR management system)

: Advanced

: Medium

:

1-3 years

Electronic purchasing software (e-SP)

Electronic purchasing software (e-SP)

: Intermediate

: Medium

:

1-3 years

Fields of Expertise

Microbiology lab

Microbiology lab

: Expert

: High

:

3-5 years

quality management

quality management

: Expert

: High

:

5-7 years

quality auditing

quality auditing

: Advanced

: Extreme - I love it!

:

1-3 years

Quality agreements

Quality agreements

: Advanced

: High

:

1-3 years

Key Skills

Analytical, Hard worker, Problem Solver, Details-oriented, Supportive

Online Presence

https://eg.linkedin.com/in/mohamed-weshahy-cmq-oe-asq-5b54341bhttps://www.facebook.com/mohamedweshahyhttps://twitter.com/mohamed_weshahy

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