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Fresenius
Fresnes
maintenant
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FRESENIUS VIAL
- Design Assurance Quality manager
2010 - 2013
* Monitored regulations and standards to demonstrate compliance of development projects in relation to regulatory requirements for Programmable Electrical Medical System (MDD 93/42 and 2007/47 amendment, 21CFR820, IEC 60601-1 and collaterals, IEC 62304, IEC 62366),
* Procured QA tools, developed QA procedures and established quality assurance methodologies/standards in order to mentor the understanding of quality objectives in the organization,
* Ensured that all development documentation meets external regulatory (CE mark, FDA, …) and internal SOP requirements,
* Worked in coordination with other departments in implementing the quality standards and benchmarks,
* Managed strategic quality projects (510k submission, requirements traceability),
* Participated for audits and inspections by world health authorities (GMED, TUV),
* Managed development improvement process (document control, risk management, requirement traceability, design control),
* Performed internal and external audits (focus on R&D suppliers).
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SEGULA TECHNOLOGIES SUD
- Quality Operations Manager
Nanterre
2007 - 2010
* Ensured that all verification and validation documentation (for bulk and formulation / filing production) meets external regulatory and internal guidelines and requirements: review and Approval of GMP design and qualification Lifecycle documents (e.g. URS, impact assessments, IQs, OQs, PQs),
* Managed Quality documentation in accordance with international QA guidelines (cGMP, EU-GMP, ISO, GAMP, ASTM),
* Prepared briefing package for inspection purpose (ANSM, FDA, OMS,…),
* Monitored regulations and standards to demonstrate QA system compliance,
* Performed verification and validation activities for bulk and formulation / filing production (wide range of equipments and process such as autoclave, oven, HVAC, water production, steam production, environmental control,...),
* Managed a project of production reliability (constant quality improvement) with a multidisciplinary team (15 engineers and technicians),
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CROSSJECT
- Validation Manager
Dijon
2002 - 2007
* Managed QA activities for R&D department,
* Elaborated and maintained Quality Management System according to international QA guidelines (cGMP, EU-GMP, GLP, GCP, ISO),
* Managed (review and Approval) of GMP design and qualification Lifecycle documents (e.g. URS, impact assessments, IOQs, PQs)
* Hired, trained and daily managed a validation team (5 engineers and technicians),
* Managed a multidisciplinary team (10 engineers and technicians),
* Managed pharmaceuticals projects (from feasibility to phase I clinical trials).
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QIAGEN
- Sales Manager
COURTABOEUF
2001 - 2001
* Promoted technical and commercial automated systems and consumables.
* Development of customer satisfaction and partnership with key accounts.
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Sanofi Aventis
- R&D Project Manager
Paris
1998 - 2000
* Validated biochip technology on murine and humans models,
* Validated specific software tools,
* Prepared scientific publication.
