Freelancer profile translated to English.
Back to original languageAbout Ebru
Quality professional in the pharmaceutical industry with solid experience in document management, quality assurance, regulatory compliance, and process optimization. I support companies in implementing, monitoring, and improving their quality systems, managing deviations, CAPAs, changes, and internal audits. My expertise also extends to regulatory intelligence, conducting gap analyses, and integrating normative requirements (GMP, ISO 13485, ICHQ9, ICHQ10...). Rigorous, organized, and adaptable, I am committed to providing effective solutions compliant with industry requirements, while facilitating team communication and training.
In parallel, I am developing CompliQuality, an innovative SaaS solution dedicated to regulatory intelligence, gap analysis, and compliance automation, designed to support companies in regulated sectors in their digital transformation and continuous improvement.
French
Native or bilingual
English
Conversational
Can work on-site
Clermont-Ferrand (up to 40km)
Experience
- THEAQuality Assurance OfficerPHARMACEUTICALS INDUSTRYSeptember 2024 - September 2025 (1 year)Clermont-Ferrand, FranceParticipate in the implementation, monitoring, and optimization of the document system and quality processes (SOPs, instructions, forms, KPIs).Train and raise awareness among teams on quality approaches and departmental processes.Open, monitor, and manage quality processes (deviations, improvement actions, change controls, CAPAs...), conduct investigations, and support teams in their resolution.Coordinate teams within the framework of cross-functional projects (transfer of activities to another site, management of direct shipments...), while ensuring the planning and monitoring of actions.Supervise and support three departments—demand management, shipping logistics, and procurement—by ensuring the updating of their quality documentation and the monitoring of their processes.
- ICARERegulatory Affairs AssistantPHARMACEUTICALS INDUSTRYMay 2023 - August 2023 (4 months)Clermont-Ferrand, FranceEstablish pharmaceutical risk management (QRM) and sterility department trend analyses.Analyze discrepancies between laboratory practices and the new requirements of GMP Annex 1.Define actions to be implemented to comply with these new requirements.Regulatory intelligenceGap analysis execution
- IcareQuality Assurance OfficerPHARMACEUTICALS INDUSTRYSeptember 2023 - September 2024 (1 year)Optimization of client contractsSupplier evaluationEstablish the specific training path for quality assurance.Optimize the process for managing non-conformities/customer complaints in the DMS.Create the internal audit process in conjunction with GMP, GLP, and standard 17025.Client contract optimization.Document management: Revision, registration, reassignment, archiving of documents
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Education
- Health Sciences Bachelor's DegreeUniversity Clermont Auvergne2022
- Master of Science in Medicines and Health ProductsUniversity Clermont Auvergne2023