Freelancer profile translated to English.
Back to original languageAbout Caroline
Driven by innovation and performance, I have over 12 years of experience in implementing GxP, Hygiene, and Safety quality management systems (QMS) in the clinical-stage biotechnology field.
I also have skills in personal data management (GDPR)
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- PHARMARKETINGGDPR & Quality ConsultantNovember 2024 - Today (1 year and 7 months)Fontenay-sous-Bois, France GDPR expertise : DPO for Clients, support on GDPR matter, Quality related activities: audit on behalf of Clients for GxP compliance suppliers assessment, support on Quality Management System matter
- ServierR&D QA QMS ExpertJune 2024 - September 2024 (3 months)Les Ulis, FranceQMS implementation in the dedicated Business Units QDS management (GED, PAQ), Gap analysis (RQA, GLP), Action plan, training, R&D lab support (data integrity from the ALCOA principles), audit program from the risk approach
- InvectysDirector QA & HSEDecember 2017 - June 2024 (6 years and 6 months)Paris, FranceHead of QA & HSE US/Fr clinical-stage biotechCreation & implementation of GxP QMS & HSE policy_ Member of the Executive Committee QDS management (Fr&US), Training (8/year), Deviation & CAPA, Audit (pre-selection, follow up, study report ; GxP); Sub-contractors management for quality matter related to :• IMP activities (QTA, IND, batch records, OOS, change control)• Clinical activities (TMF, contracts, ICF); R&D lab support (equipment & lab qualification, biobanking) HSE activities (risk assessment, action plan, training, documents); Act as DPO, MR001 ; GDPR)
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Education
- Master's degree Scientific Instrumentation & QualityReims2012Master's degree Scientific Instrumentation & Quality
- Bachelor's Degree Biology, Biochemistry, Earth and EnvironmentReims2010Bachelor's Degree Biology, Biochemistry, Earth and Environment