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Hays
- Pharmacien en assurance qualité
Paris
2015 - maintenant
Sanofi R&D, Assurance qualité clinique
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Sanofi
- Process and quality document manager
Paris
2013 - maintenant
Process & Quality Document Manager at Quality & Continuous Improvement Department: R&D Clinical Science & Operations: SANOFI:
Missions:
- Responsible, working in close collaboration with business owners, to develop key platform business processes and produce the associated Quality Documents which are part of those standards required by Regulatory Authorities for compliance to Good Clinical Practice (GCP) and related regulations;
- Leader representing the Quality & Continuous Improvement Dept within transversal working groups which are established to develop or revise business processes.
- Lead meetings/ working groups to develop Quality Document and coordinate with other departments to ensure harmonization of processes;
- Provide support to the platform teams about business processes/ Quality Document related matters;
- Provide support to business owners/ stakeholders to define business processes and propose solutions for improvement;
- Support end-users in questions related to the platform processes;
- Collaborate with each Quality & Continuous Improvement Training, Information-Sharing, Quality Assessment Units and Quality Network to assure integration of expertise and process improvement solutions in Quality Documents;
- Collaborate with the Quality & Continuous Improvement Process Management’s References Administration sub-unit for the development of eMAPs (that describe processes), preparation and approval of Quality Documents, and subsequent publication.
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AGEPS
- Pharmacist in clinical trials (Supply chain coordinator)
2008 - 2012
Pharmacist coordinator at the clinical trials department of AGEPS (pharmaceutical company of Paris's hospitals: APHP): pharmaceutical management of the clinical trials of Paris's hospitals research direction (supply chain).
Missions:
- Project manager (~ 8 clinical trials/year) to set up the pharmaceutical part
- Pharmaceutical analysis of the protocols;
- Drafting and implementation of pharmaceutical circuits of clinical trials;
- Audit: Preparation of the audits, conducting audits, writing reports, Audit Progress
- Management of technical team (~ 10 persons) for secondary packaging and logistics;
- Management of secondary packaging and labeling operations;
- Management of subcontracting of manufacturing and packaging;
- Management of Units shipment to the investigators' sites in France (cold chain included);
- Management of batch recalls;
- Drafting documents of packaging, shipping, return and destruction of the new clinical trial protocols;
- Drafting and updating internal procedures to be in compliance with the activity enhancement of the department and with the GCP, GMP and GDP;
- Collaboration for the implementation and monitoring of clinical trials with other stakeholders at Clinical Research Units, hospital pharmacies, the Department of Clinical Research of APHP, subcontractors and the pharmaceutical companies.
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CHU Saint-antoine Paris - PUI
- Pharmacist at the pharmacy of Saint-Antoine hospital APHP
2007 - 2008
- Clinical trials drugs and "Temporary Authorization for Use" drugs management;
- Drug Supply of the investigators centers in the hospital;
- Clinical trials drugs dispensing...
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CHU André Grégoire de Montreuil
- Pharmacist at the pharmacy of André Grégoire hospital of Montreuil
2007 - 2007
- Management of pharmacology - toxicology Lab
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Hôpital européen Georges Pompidou Paris : laboratoire de pharmacologie
- Internship of master 2 of pharmacology at the HEGP hospital Lab of pharmacology
2006 - 2007
Quantification of the metabolic pharmacokinetic drug interactions involving CYP 3A4: application on the immunosuppressive - azol antifungal drugs association on lung transplant patients with cystic fibrosis
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CHU andré Grégoire Montreuil
- Pharmacist at the pharmacy of André Grégoire hospital of Montreuil
2006 - 2006
Management of pharmacology - toxicology Lab
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Laboratoire de pharmacologie-toxicologie de l'Hôpital Européen Georges Pompidou
- Internship at HEGP hospital Lab of pharmacology for master 1
2006 - 2006
