أحمد Alyamany

QA Manager·SAJA Pharmaceuticals Egypt

مصر

ماجستير, strategic management

الخبرة العملية

مجموع سنوات الخبرة: 24 سنوات, 6 أشهر

QA Manager

مارس 2018 - حتى الآن

SAJA Pharmaceuticals Egypt

القاهرة، مصر

مارس 2018 - حتى الآن

• 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.

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

QA Manager

يناير 2017 - فبراير 2018

Razi-Almadinah

المدينه المنوره، المملكة العربية السعودية

يناير 2017 - فبراير 2018

Managed the facility qualification phase, developed quality management system and obtained Saudi FDA GMP approval for the site.

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

Quality assurance assistant manager

ديسمبر 2015 - يناير 2017

Future pharmaceutical industry (FPi)

القاهرة، مصر

ديسمبر 2015 - يناير 2017

Maintained quality compliance and passed all audits (Abbott, Sandoz, Yemen MOH and Sudan MOH).

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

Validation manager

أكتوبر 2014 - سبتمبر 2015

Arabio

مكة المكرمة، المملكة العربية السعودية

أكتوبر 2014 - سبتمبر 2015

Responsible for all validation activities.

Successfully completed technology transfer project with GSK vaccines Wavre, Belgium.
Passed audits by GSK and Saudi FDA.

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

Quality manager

مارس 2012 - أكتوبر 2014

Badr Pharma

القاهرة، مصر

وجدت هذه الوظيفة عبر بيت.كوم

مارس 2012 - أكتوبر 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.

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

QA supervisor

يناير 2010 - يناير 2012

Saudi Arabian Japanese pharmaceutical industries co.( SAJA)

جدة، المملكة العربية السعودية

يناير 2010 - يناير 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)

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

Quality Assurance Inspector

يونيو 2005 - يناير 2010

Saudi Arabian Japanese pharmaceutical industeries company (SAJA)

جدة، المملكة العربية السعودية

يونيو 2005 - يناير 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)

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: غيرذلك

quality assurance pharmacist

سبتمبر 2001 - يونيو 2005

EIPICO

مصر

سبتمبر 2001 - يونيو 2005

responsible for quality system conformance to quality standards (iso 9000:2000, cGMP)
- internal audit team member
- annual product review
- Batch record review

مجال الشركة:: صناعة الدواء
الدور الوظيفي:: مراقبة الجودة

التعليم

Arab Academy For Science, Technology & Maritime Transport

أغسطس 2020

ماجستير، strategic management

مصر

المعدل التراكمي (نقاط): 3.8 من 4

American Society for Quality (ASQ)

يونيو 2014

دبلوم، Cerified Pharmaceutical GMP professional (CPGP)

مصر

AIQM (accredited by ASCB(E) Uniterd Kingdom)

مايو 2009

دبلوم، Six Sigma green belt

المملكة العربية السعودية

Grade A+

Nigel Bauer & Associates (United kingdom)

أغسطس 2008

دبلوم، IRCA certificated lead auditor for quality management

المملكة العربية السعودية

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

faculty of pharmacy /zagazig university

مايو 2001

بكالوريوس، good

مصر

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

اللغات

الانجليزية

المستوى: متمرّس

العضويات

Saudi Quality Council (SQC)

member

April 2009

ISPE(international society of pharmaceutical engineering)

member

December 2010

American society for quality ASQ

member

September 2013

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تصفح الوظائف

وظائف في مصر

أحمد Alyamany

مشاركة سيرتي الذاتية

الخبرة العملية

QA Manager

QA Manager

Quality assurance assistant manager

Validation manager

Quality manager

QA supervisor

Quality Assurance Inspector

quality assurance pharmacist

التعليم

Arab Academy For Science, Technology & Maritime Transport

American Society for Quality (ASQ)

AIQM (accredited by ASCB(E) Uniterd Kingdom)

Nigel Bauer & Associates (United kingdom)

faculty of pharmacy /zagazig university

Skills

اللغات

العضويات

Saudi Quality Council (SQC)

ISPE(international society of pharmaceutical engineering)

American society for quality ASQ