Imane Rebah
Quality Assurance Systems | QA Compliance | GxP Audits | QMS ISO/ICH Pharmaceuticals & Médical Devices – Regulatory mindset
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Over
Quality Assurance professional with 10 years of experience within pharmaceutical regulatory authorities, specialized in GMP/GLP/GDP audits, regulatory compliance, Quality Management System (QMS) assessment, and CAPA effectiveness. Recognized expertise in evaluating the quality systems of manufacturers, quality control laboratories, storage facilities, and distributors in accordance with ICH Q10, GMP, GDP, ISO/IEC 17025, and ISO 31000 requirements.
Ervaring
Quality Audit Coordinator – Pharmaceutical & Medical Device Manufacturers, Storage & Distribution - National Agency of Pharmaceutical Products (ANPP)
(2020-07 - 2023-10)
- Planned and conducted GMP / GLP / GDP regulatory audits of manufacturers, QC laboratories, storage facilities, and distributors.
- Performed in-depth QMS assessments in line with ICH Q10, GMP, GDP, and ISO standards.
- Reviewed deviations, CAPA, change control, data integrity, and risk management processes.
- Critically reviewed regulatory documentation (SOPs, PQRs, qualifications, validations, QC reports).
- Identified critical, major, and minor non-conformities.
- Issued audit reports supporting regulatory decisions related to authorization, continuation, or suspension of activities.
- Assessed the relevance and effectiveness of CAPA implemented by audited sites.
Quality Coordinator – National Official Medicines Control Laboratory - National laboratory control of Pharmaceutical Products (LNCPP)
(2013-12 - 2020-07)
- Led and continuously improved the QMS in compliance with GMP, ISO/IEC 17025, ICH, and WHO requirements.
- SOP review, document management, and analytical traceability.
- Participated in internal audits, accreditation audits, and WHO inspections.
- Managed quality deviations and CAPA.
- Participated in GMP/GLP audits of manufacturers' QC laboratories.
- Delivered training on quality requirements and good practices.
R&D Pharmaceutical Internship - SANOFI France
(2012-03 - 2012-09)
- Analytical and preclinical development
- Crystallography, X-ray diffraction, molecular modeling
- Work performed in a GMP-compliant pharmaceutical environment.
Personal transition & Administrative relocation to Belgium
(2023-10)
Opleiding
Master's Degree - BIOTIN : Project Management and innovation in Biotechnology - University of Montpellier, France
