Freelancer profile translated to English.
Back to original languageAbout Houda
Quality Assurance Pharmacist registered with the order section B
Operational Quality Assurance; certification and release of batches; management of Quality Technical Agreements (QTA); management of distribution deviations and temperature excursions; complaint processing; transition project management; continuous improvement; pharmaceutical production; distribution; pharmaceutical affairs; commercial affairs management; pharmaceutical and biotechnology industry
French
Native or bilingual
English
Fluent
Arabic
Fluent
Can work on-site
Paris (up to 50km)
Experience
- SeptodontDistribution Quality Assurance ManagerPHARMACEUTICALS INDUSTRYMay 2024 - Today (2 years and 1 month)Croissy-sur-Seine, FranceManager of distribution center activities• Management of non-conformities, deviations, and associated preventive and corrective actions for these activities• Management of distribution activities• Management of customer and logistics complaints• Deployment, animation, verification, and improvement of quality and the quality system in compliance with applicable quality standards (GXP, GVP, ISO13485,)• Preparation and participation in audits and inspections by competent authorities• Conducting audits as part of distributor accreditation and monitoring• Quality management and monitoring of distributors• Management of Change Controls (CCR) related to these activities• Handling of temperature excursions• Approval and validation of destructions• Management of the distribution team
- IpsenGlobal Quality Manager - Commercial OperationsPHARMACEUTICALS INDUSTRYNovember 2021 - September 2023 (1 year and 10 months)Boulogne-Billancourt, FranceDeployment of the quality management system in subsidiaries:• Supervision and implementation of the Quality Management System (QMS) in collaboration with other GxP functions• Definition of the roadmap for the deployment and consolidation of quality system elements• Coordination with commercial operations on QMS deploymentGxP Compliance Assurance:• Preparation and participation in about twenty audits• Development and verification of the implementation and monitoring of pre-established checklists• Follow-up of audit CAPAs and all non-conformities, if any• Strengthening of risk management culture• Implementation of company documents and regional SOPs• Implementation of a comprehensive GxP training program• Strengthening and optimization of the Quality culture in subsidiaries and partners• Structured communication with subsidiaries and partners• Updating of Quality Technical Agreements with countries and partnersSupport for Quality activities with subsidiaries and partners:• Management of complaints, changes, and deviations
- ALK ABELLOQuality Assurance ManagerPHARMACEUTICALS INDUSTRYJanuary 2021 - October 2021 (9 months)Paris, France• Management of the quality assurance team• Steering the quality system in conjunction with the operating site's activities and organizing Product and System Quality reviews• Document management and distribution of procedures• Harmonization of French Quality documentation with Group procedures• Preparation and participation in operating site inspections, group audits, and certification audits for canvassing or prospecting activities aimed at promoting medicines, and follow-up of resulting action plans• Planning, execution, and monitoring of internal and external audits concerning the operating site's activities• Processing of complaints and batch recalls concerning pharmaceutical specialties and the operating site's activities• Monitoring of activities related to the distribution of pharmaceutical specialties: batch tracking• Development of specifications and quality monitoring of service providers• Management of changes related to specialties and the operating site• Preparation and submission of annual site status reports• Taking charge of IT validation for local systems
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Education
- Doctor of PharmacyFaculty of Pharmacy, University of Paris Sud XI2019THESE : Gestion des Résultats Hors Spécifications Appliqués à des Produits Issus des Biotechnologies Sous la direction de Prof. Dr. Najat Yagoubi
- Master 2 Quality ManagementFaculty of Pharmacy, University of Paris Sud XI2016