Freelancer profile translated to English.
Back to original languageAbout Josseline
Quality Assurance Specialist (5 years of experience), ensuring operational monitoring, document management, training, and continuous improvement in regulated environments (medicines and medical devices).
Accustomed to international interactions and cross-functional environments, and comfortable with tools (SAP, Trackwise, EBX, eDMS, etc.)
Depending on the type of mission and the possibility of remote work, I can travel throughout France.
French
Native or bilingual
English
Fluent
Italian
Fluent
Can work on-site
Paris (up to 50km)
Experience
- Fresenius Medical CareQA Officer (Fixed-term contract)PHARMACEUTICALS INDUSTRYApril 2024 - September 2025 (1 year and 5 months)Fresnes, FranceGDP/GMP/ISO 13485 / MDR 2017/745 environments:
- Quality monitoring of medicines and medical device batches in SAP and cross-functional coordination with Supply Chain, Sales Admin, Customer Service, and warehouse.
- Management of deviations, complaints, and quality disputes in Trackwise with CAPA management and associated KPI monitoring.
- Contribution to the implementation of the eDMS: validation, rights management, user support and training; monitoring of associated change control.
- Conducting a documentary assessment and deploying a plan to harmonize local quality procedures with group procedures.
- Conducting self-inspections, issuing reports, and proposing corrective actions.
- Monitoring regulatory training compliance (BPDG, pharmacovigilance) via KPIs and follow-ups as necessary.
- Participation in the preparation of the management review and the annual assessment.
- Audensiel HealthcareQuality Consultant (Permanent contract)PHARMACEUTICALS INDUSTRYApril 2022 - March 2024 (1 year and 11 months)Consultant for Les Laboratoires Servier in a GDP/GMP environment:
- Ensure the compliance of exceptional shipments of finished products (No Marketing Authorization, compassionate use medicine, etc.)
- Cross-functional coordination (Supply Chain, Global Regulatory Affairs, Customer Service); Unblocking batches in EBX/SAP tools and traceability;
- Management of deviations related to shipment non-conformities, investigation coordination, and action follow-up.
- Support for internal supply chain audits.
- Updating quality documentation.
- PETNET SolutionsProduction Pharmacist (Permanent contract)PHARMACEUTICALS INDUSTRYOctober 2021 - February 2022 (4 months)GMP environment, sterile injectable production site
- Review of batch records for injectable radiopharmaceutical products (release of raw materials, packaging materials, and finished products).
- Incident management and production reorganization.
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Education
- Master in QualityUniversité Paris Sud2018Master Qualité des
- Degree in PharmacyUniversità degli Studi di Roma Tor Vergata2017Diplôme de Pharmacien
Categories
- Other