Ahmed Mohamed Abdallah
Dubai,United Arab Emirates
Summary
Experienced professional with a strong background in quality systems management, risk management, and auditing proficiency. Demonstrates a comprehensive understanding of regulatory compliance and a continuous improvement mindset with focus on team leadership. Proven track record in project management and performance metrics analysis, underpinned by strong business acumen and leveraging skills to drive organizational success and foster operational excellence.
Overview
18
18
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Novartis Country Quality Manager - Gulf Cluster
Novartis Middle East FZE
Dubai, United Arab Emirates
07.2022 - Current
- Provide quality oversight and governance to implement and maintain the quality system in accordance with the Novartis quality manual, and the local regulatory requirements.
- Address any non-compliance via adequate corrective and preventive actions (CAPA).
- Coordinate with regulatory affairs and patient safety to assess the ramifications of regulatory changes, and apply the requirements.
- Oversee the third-party vendors' GxP activities to ensure compliance with good storage and distribution practice of our pharmaceutical products.
- Establish and maintain QA Agreements with all third-party vendors.
- Lead quality investigations (deviations and customer complaints), and quality incidents (escalations and recalls).
- Facilitate the change control process.
- Perform periodic self-inspection to review and enforce compliance within the organisation.
- Act as the country pharma organisation (CPO) qualified person (QP) with the release authority to ensure that all finished products and investigational medicinal products, are released.
- Lead the data integrity implemtation across the Gulf organization.
Quality Control (QC) Head
Gulf Pharmaceutical Industries (Julphar)
Ras Al-Khaimah, United Arab Emirates
03.2021 - 06.2022
- Organize, control, and implement quality management system in all related area concerning the quality control and analytical science and technology
- Liaise with other departments in implementing current Good Manufacturing Practices (cGMP) complying with MOHAP, WHO, EU and US-FDA requirements
- Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements
- Collaborates with management and senior staff across different departments and roles to develop and implement the quality standard
- Support the business development and strategy deployment through introduction of new products and test methods
- Reinforcement of the quality culture and awareness by the right practices
- Maintain cGMP principles and GLP practices
- Perform self-inspections and internal audits, in addition to acting as QC subject matter expert for regulatory and customer audits
- Control of departmental operational and capital and expense budgets to ensure it runs in a cost-effective manner.
Supplier Quality (SQ) Manager - MEA Cluster
GlaxoSmithKline (GSK)
Cairo, Egypt
09.2019 - 02.2021
- Provide QA input into procurement sourcing strategies and into new product supply strategies
- Lead quality agreement negotiations with contract manufacturing organizations (CMO) and third-party suppliers
- Carry out investigations into significant quality incidents arising at suppliers / CMO suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented
- Work with external suppliers to establish effective CAPAs, in response to GSK audit observations
- Provide relevant support to key suppliers and GSK sites undergoing regulatory inspections
- Drive periodic review of quality systems at the external suppliers and identify areas for improvement across the supply base
- Provide information to other audit teams as part of assessment preparation.
Operational Quality (OQ) Manager
GlaxoSmithKline (GSK)
Cairo, Egypt
12.2017 - 08.2019
- Manage quality investigations (deviations, customer complaints and out of specifications) and quality incidents
- Manage documentation life cycle and ensure that data integrity requirements are followed
- Approval of the stream periodic product reviews
- Manage LIC, PIRC, recall functions in coordination with site quality head
- Manage quality and technical interfaces between the site and auditors during level 3 and 4 audits
- Manage ministry of health routine inspections and communications
- Influence quality improvement programs with the aim of reducing rejects and customer complaints
- Ensure business continuity through risks identification and mitigation (RMPO).
Quality Compliance Manager
GlaxoSmithKline (GSK)
Cairo, Egypt
03.2017 - 11.2017
- Implement and maintain Quality Management System (QMS Champion) in the site
- Ensure compliance with the local regulatory authorities and export markets and QMS
- Handling of global and regulatory audits scheduling and responses
- Own, perform and maintain internal auditing systems and quality alerts in the site
- Ensure that risks to patients, consumers, regulators and GSK are being managed effectively, and escalated to the appropriate management level
- Data integrity Champion (lead the implementation of data integrity requirements on site)
- Perform periodic evaluation of service providers and create quality agreements with them
- Organize the Site Quality Council (SQC) to present all quality matters to the senior managers
- Responsible to improve the site Quality Risk Model (QRM Champion)
- Management of site change control and periodic product review process.
Quality Control Manager
GlaxoSmithKline (GSK)
Cairo, Egypt
07.2013 - 02.2017
- Ensure that all analytical and microbiology laboratories activities operate in compliance with QMS, GMP, EHS regulations and local regulatory requirements
- Perform self-inspections and internal audits, in addition to acting as QC subject matter expert for Level 3 and Level 4 audits
- Support the business strategy deployment and technology transfer through introduction of new products and test methods
- Manage departmental capital and expense budgets to ensure it runs in a cost effective manner
- Member of the GMP training team that aims at raising awareness of all staff members
- Coordinate the provision of appropriate and timely training to all team members, ensuring their competence for the assigned tasks.
Technical Service (TS) Section Head
GlaxoSmithKline (GSK)
Cairo, Egypt
06.2011 - 07.2013
- Prepare the capital plan for the QC department
- Supervise the laboratory calibration system to ensure that the equipment are continuously ready for use
- Design a robust maintenance system for lab equipment which complies with CAP, QMS and GES requirements
- Plan for the laboratory method development, validation, in-vitro bioequivalence studies and technical support, whenever needed
- Lead analytical knowledge transfer process between GSK Cairo and other sites in the network or third party manufacturers
- Perform self-inspection audits to ensure compliance with local procedures and policies.
Technical Service (TS) Analyst
GlaxoSmithKline (GSK)
Cairo, Egypt
01.2007 - 06.2011
- Operate and calibrate analytical equipment and instruments in QC lab
- Test and analyze intermediates, finished products and cleaning validation samples
- Test stability samples as per stability schedule and manage reference standards in QC Lab
- Develop, verify, validate and review methods of analysis
- Analytical method transfer between Cairo site and other sites, such as, Brasov (Romania) and Giza
- Investigate and report out of specification (OOS) and atypical results
- Internal audit team member
- Participate in validation of spreadsheet and analytical equipment project within the chemical laboratory.
Education
Master of Business Administration - Global Managament
Paris ESLSCA business school
Cairo, Egypt 09.2019 - 06.2021
Bachelor of Pharmaceutical Sciences - Pharmaceutical Sciences
Faculty of Pharmacy, Ain Shams University
Cairo, Egypt 09.2001 - 06.2006
Skills
- Quality systems management
- Risk management
- Auditing proficiency
- Regulatory compliance understanding
- Continuous improvement mindset
- Project management experience
- Performance metrics analysis
- Strong business acumen
Certification
Licensed Pharmacist by MOHAP, Oct 2022
Auditor Certification Program, Jun 2016
Languages
English
Fluent
Arabic
Native
Timeline
Novartis Country Quality Manager - Gulf Cluster
Novartis Middle East FZE
07.2022 - Current
Quality Control (QC) Head
Gulf Pharmaceutical Industries (Julphar)
03.2021 - 06.2022
Master of Business Administration - Global Managament
Paris ESLSCA business school
09.2019 - 06.2021
Supplier Quality (SQ) Manager - MEA Cluster
GlaxoSmithKline (GSK)
09.2019 - 02.2021
Operational Quality (OQ) Manager
GlaxoSmithKline (GSK)
12.2017 - 08.2019
Quality Compliance Manager
GlaxoSmithKline (GSK)
03.2017 - 11.2017
Quality Control Manager
GlaxoSmithKline (GSK)
07.2013 - 02.2017
Technical Service (TS) Section Head
GlaxoSmithKline (GSK)
06.2011 - 07.2013
Technical Service (TS) Analyst
GlaxoSmithKline (GSK)
01.2007 - 06.2011
Bachelor of Pharmaceutical Sciences - Pharmaceutical Sciences
Faculty of Pharmacy, Ain Shams University
09.2001 - 06.2006
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