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Ahmed Alyamany, QA Manager

Ahmed Alyamany

QA Manager·SAJA Pharmaceuticals Egypt

Egypt

Master's degree, strategic management

Work experience

Total years of experience: 24 years, 6 months

QA Manager

March 2018 - Present

SAJA Pharmaceuticals Egypt

Cairo, Egypt

March 2018 - Present

• Set the strategy of QA department.
• Enrich quality culture.
• Lead QA team (staff development, coaching and support).
• Plan and control the Budget of QA department.
• Drive improvements of all the Quality systems, such as complaints, change control, deviations and compliance programs to ensure they are robust and effective to support the activities of the pharmaceutical operations, maintaining a high level of GMP to meet the expectations of regulatory and Company requirements.
• Ensure in association with other departments, that the requirements of GMP are observed so that conditions of the Manufacturing and Marketing Authorizations are met and retained.
• Ensure all activities performed by 3rd Parties or suppliers are in compliance with both the regulatory and company GMP requirements. To perform required audits of 3rd Parties and suppliers and to ensure Quality Agreements are in place and maintained according to the relevant regulatory requirements.
• Manage validation and qualification program.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

QA Manager

January 2017 - February 2018

Razi-Almadinah

Medina, Saudi Arabia

January 2017 - February 2018

Managed the facility qualification phase, developed quality management system and obtained Saudi FDA GMP approval for the site.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Quality assurance assistant manager

December 2015 - January 2017

Future pharmaceutical industry (FPi)

Cairo, Egypt

December 2015 - January 2017

Maintained quality compliance and passed all audits (Abbott, Sandoz, Yemen MOH and Sudan MOH).
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Validation manager

October 2014 - September 2015

Arabio

Mecca, Saudi Arabia

October 2014 - September 2015

Responsible for all validation activities.

Successfully completed technology transfer project with GSK vaccines Wavre, Belgium.
Passed audits by GSK and Saudi FDA.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Quality manager

March 2012 - October 2014

Badr Pharma

Cairo, Egypt

I found this job using Bayt.com

March 2012 - October 2014

• Revise plant layout to ensure GMP compliance;
• Revise personnel flow and materials flow;
• Develop validation master plan and validation protocols;
• Coach all commissioning, qualification and validation activities of all equipment and systems (Water system, HVAC, process equipment and analytical devices);
• Prepare quality manual and site master file;
• Develop quality management system (SOPs, Specifications and test methods, Batch records);
• Assign plant start up requirements;
• Hire QA, QC and microbiology staff;
• Lead QA, QC and microbiology staff;
• Manage QC lab.;
• Manage product compliance and release issues;
• Passed MOH certification audit.
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

QA supervisor

January 2010 - January 2012

Saudi Arabian Japanese pharmaceutical industries co.( SAJA)

Jeddah, Saudi Arabia

January 2010 - January 2012

Responsibilities:
• Supervision of QA staff
• Supplier approval and Supplier quality audit
• Pharmaceutical distributor quality audit
• Internal quality audit
• Handling of customer complaints
• Training
• Validation
• Handling of non conformances, investigations, corrective/ preventive actions & follow up.
• Check different quality documents (site master file, validation protocols, SOPs, log books, … etc)



Audits conducted:


* API suppliers:

Chemo-Liconsa (Madrid -spain)
Ercros (Madrid spain)

* Packaging materials suppliers:

JGC (Jeddah Saudi Arabia)
NasrPack (Jeddah Saudi Arabia)
Al-Banawi (Jeddah Saudi Arabia)


* Whole sale distributors:

FDC (Beirut-Lebanon)
Tamer (Jeddah Saudi Arabia)
Multipharma (Cairo-Egypt)

* Contract manufacturers:

Prodiphal (Algeria)
Pharmalliance (Algeria)

* Calibration labs:

SAECO calibration lab (Al-Khobar-Saudi Arabia)
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Quality Assurance Inspector

June 2005 - January 2010

Saudi Arabian Japanese pharmaceutical industeries company (SAJA)

Jeddah, Saudi Arabia

June 2005 - January 2010

I have the following responsibilities:

- Compile QA documents (Site master file, SOPs, forms and log books)
- Check other departments documents(BMR & BPR, SOPs, forms, log books)
- Monitor GMP compliance.
- Perform Internal quality audit.
-Make Annual product review, statistical process analysis and process capability studies.
-Responsible for CAPA system ( handling of non conformances, investigations and root cause analysis, corrective and preventive actions, effectiveness check for root cause analysis and corrective/preventive actions).
- Perform Cleaning validation studies (protocol preparation, limits calculations, swab sampling and issue final report)
- Review batch records before product release.
- Handle customer complaints (investigations and root cause analysis, corrective and preventive actions, customer contact to ensure satisfaction)
- Perform training for company staff (GMP, total quality management, quality management system auditing)
Company industry:
Pharmaceutical Manufacturing
Job role:
Other

quality assurance pharmacist

September 2001 - June 2005

EIPICO

Egypt

September 2001 - June 2005

responsible for quality system conformance to quality standards (iso 9000:2000, cGMP)
- internal audit team member
- annual product review
- Batch record review
Company industry:
Pharmaceutical Manufacturing
Job role:
Quality Control

Education

Arab Academy For Science, Technology & Maritime Transport

August 2020

August 2020

Master's degree, strategic management

Egypt

GPA (point): 3.8 out of 4

GPA (point): 3.8 out of 4

American Society for Quality (ASQ)

June 2014

June 2014

Diploma, Cerified Pharmaceutical GMP professional (CPGP)

Egypt

AIQM (accredited by ASCB(E) Uniterd Kingdom)

May 2009

May 2009

Diploma, Six Sigma green belt

Saudi Arabia

Grade A+

Nigel Bauer & Associates (United kingdom)

August 2008

August 2008

Diploma, IRCA certificated lead auditor for quality management

Saudi Arabia

The certifying body is IRCA (International register of certificated auditors)

faculty of pharmacy /zagazig university

May 2001

May 2001

Bachelor's degree, good

Egypt

Skills

Quality Management
Expert
Quality Management
Expert
Quality Assurance
Expert
Quality Assurance
Expert
Leadership
Expert
Leadership
Expert
Green Belt
Expert
Green Belt
Expert
GMP
Expert
GMP
Expert
Computer (Ms office)
Expert
Computer (Ms office)
Expert
Validation
Expert
Validation
Expert
GMP
Expert
GMP
Expert
Quality Management
Expert
Quality Management
Expert
Quality Assurance
Expert
Quality Assurance
Expert
Leadership
Expert
Leadership
Expert
Green Belt
Expert
Green Belt
Expert

Languages

English
Expert

Memberships

Saudi Quality Council (SQC)

member

April 2009

ISPE(international society of pharmaceutical engineering)

member

December 2010

American society for quality ASQ

member

September 2013