
Abanoub Rady Mazen
QA Operations Specialist at Sanofi
Haram, Giza, EgyptWork Experience
QA Operations SpecialistFull Time
Sanofi
Jun 2025 - Present -1 month
Egypt , Cairo
- Job Details:- Contribute to the implementation, execution, and continuous improvement of the site’s Quality Assurance systems in alignment with GMP, Sanofi global standards, and regulatory requirements. - Perform routine QA oversight on production activities to ensure compliance with batch records, SOPs, and critical GMP controls. - Manage deviations, support root cause investigations, and ensure timely and effective CAPA implementation to maintain product quality and data integrity. - Perform batch record review and support the batch release process to ensure product quality and compliance before distribution. - Collaborate with cross-functional teams including Production, QC, and Engineering to ensure timely resolution of quality-related issues and support continuous improvement.
Senior Quality Assurance SpecialistFull Time
Oct 2024 - May 2025 -7 months
Egypt , Giza
- Job Details:Leading the Qualification Team within the Quality Assurance department, responsible for overseeing and executing all qualification activities across five production sites: Solid Dosage Forms, Cephalosporins Sterile Powder Filling, Soft-Gelatin Capsules, Sterile Liquid Filling, and Vaccine manufacturing areas in EVA Pharma 6th of October Industrial Complex. Key responsibilities include: - Managing the execution and documentation of routine and non-routine qualification activities (Cleanrooms, Autoclaves, Depyrogenation tunnels, Water Systems, SIP, Compressed Air, Visual Inspection, and Thermal Mapping) - Ensuring compliance with international regulatory standards (EU, FDA, WHO) - Ensuring audit readiness and representing the department during audits
Quality Assurance Specialist: Validation & QualificationFull Time
Dec 2022 - Oct 2024 -1 yr, 10 months
Egypt , Giza
- Job Details:- Process Validation for Solid Dosage Forms Area - Equipment and Machines Qualification - Aseptic Process Simulation (APS) for Sterile Liquid Filling Area - HVAC system Qualification in classified cleanroom areas - Steam Sterilization Autoclaves Performance Qualification - Sterile Powder Filling In-Process Control (IPC) oversight on the production floor - Ensured GMP compliance across all operations and supported inspection readiness for regulatory audits.
Education
Bachelor's Degree in Pharmacy
Assiut University (AUN)Jan 2017 - Jan 2022 - 5 yr
Languages
Arabic
FluentEnglish
Advanced
Training & Certifications
Lean Six Sigma Green Belt (LSSGB)
Kennesaw University·2024Aseptic Process Simulation (Media Fills)
FDA Compounding Quality Center of Excellence·2024Investigations and Corrective and Preventive Actions (CAPA)
FDA Compounding Quality Center of Excellence·2023Training on Air Quality Tests
Akhnaton Trading and Representation·2023Cleanroom Design and Certification
RSSL·2023Foundations of GMP
US Pharmacopeia·2022Introduction to Data Analysis using Microsoft Excel
Coursera Project Network·2022Drug Commercialization
University of California San Diego·2021Business Communication Skills
Udemy·2020Basic Life Support Provider Certification Course
National Health Care Provider Solutions·2020