-
QA department
- Directeur & Global Head Quality Assurance
2012 - maintenant
Directeur, Global Head Quality Assurance - Nanobiotix -
- Creation of a new QA department following departure of current global head with definition of position and recruitment of
8 people from engineer to pharmacist status,
-------
- Management of full Quality department including Budget, Performance objectives and professional excellence development for the team,
- Implementation Global integrated Quality system to support Nanobiotix challenges in both medical device and Drugs fields wordwilde for full product life cycle from discovery to commercialization and post market surveillance,
- Implementation of Pharmaceutical system for IPA production site and contribute in global pharmaceutical development process (ICH Q8/Q9/Q10),
- Increase Quality culture for clinical research and Review of the clinical QA system as per ICH E6(R2)
- Digitalization and softwares validation of Quality processes
- Contribution to MDR implementation for Class III sterile medical device.
-
QA department
- Directeur & Global Head Quality Assurance
2012 - maintenant
Directeur, Global Head Quality Assurance - Nanobiotix -
- Creation of a new QA department following departure of current global head with definition of position and recruitment of
8 people from engineer to pharmacist status,
-------
- Management of full Quality department including Budget, Performance objectives and professional excellence development for the team,
- Implementation Global integrated Quality system to support Nanobiotix challenges in both medical device and Drugs fields wordwilde for full product life cycle from discovery to commercialization and post market surveillance,
- Implementation of Pharmaceutical system for IPA production site and contribute in global pharmaceutical development process (ICH Q8/Q9/Q10),
- Increase Quality culture for clinical research and Review of the clinical QA system as per ICH E6(R2)
- Digitalization and softwares validation of Quality processes
- Contribution to MDR implementation for Class III sterile medical device.
-
QA department
- Directeur & Global Head Quality Assurance
2012 - maintenant
Directeur, Global Head Quality Assurance - Nanobiotix -
- Creation of a new QA department following departure of current global head with definition of position and recruitment of
8 people from engineer to pharmacist status,
-------
- Management of full Quality department including Budget, Performance objectives and professional excellence development for the team,
- Implementation Global integrated Quality system to support Nanobiotix challenges in both medical device and Drugs fields wordwilde for full product life cycle from discovery to commercialization and post market surveillance,
- Implementation of Pharmaceutical system for IPA production site and contribute in global pharmaceutical development process (ICH Q8/Q9/Q10),
- Increase Quality culture for clinical research and Review of the clinical QA system as per ICH E6(R2)
- Digitalization and softwares validation of Quality processes
- Contribution to MDR implementation for Class III sterile medical device.
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Sedifa
- Head of Quality Assurance
2008 - 2012
Head of Quality Assurance - Sedifa/Exsymol - -------
- Successfully managed inspections by National Competent Authorities (NCA) for GMP certification maintenance
- Successfully managed Inspections by NCA in the context of GLP certification for in vivo and in vitro studies
- Successfully managed audits for ISO 13485 and MDD certifications (CE Mark)
- Establishment and maintenance of full Quality Management System according to GxP for medicinal products (specifically GLP and GMP) and Medical Device regulations as per MDD 93/42/CEE and ISO 13485:2003.
- Follow up of external projects for implementation of Quality System for Active Pharmaceutical Ingredient (ICHQ7A) and contribute to the implementation of new REACH regulation,
- Application for registration of class III, implantable sterile Medical Device in Europe (CE Mark), Asia, South America and Middle Est.
-
Sedifa
- Head of Quality Assurance
2008 - 2012
Head of Quality Assurance - Sedifa/Exsymol - -------
- Successfully managed inspections by National Competent Authorities (NCA) for GMP certification maintenance
- Successfully managed Inspections by NCA in the context of GLP certification for in vivo and in vitro studies
- Successfully managed audits for ISO 13485 and MDD certifications (CE Mark)
- Establishment and maintenance of full Quality Management System according to GxP for medicinal products (specifically GLP and GMP) and Medical Device regulations as per MDD 93/42/CEE and ISO 13485:2003.
- Follow up of external projects for implementation of Quality System for Active Pharmaceutical Ingredient (ICHQ7A) and contribute to the implementation of new REACH regulation,
- Application for registration of class III, implantable sterile Medical Device in Europe (CE Mark), Asia, South America and Middle Est.
-
Sedifa
- Head of Quality Assurance
2008 - 2012
Head of Quality Assurance - Sedifa/Exsymol - -------
- Successfully managed inspections by National Competent Authorities (NCA) for GMP certification maintenance
- Successfully managed Inspections by NCA in the context of GLP certification for in vivo and in vitro studies
- Successfully managed audits for ISO 13485 and MDD certifications (CE Mark)
- Establishment and maintenance of full Quality Management System according to GxP for medicinal products (specifically GLP and GMP) and Medical Device regulations as per MDD 93/42/CEE and ISO 13485:2003.
- Follow up of external projects for implementation of Quality System for Active Pharmaceutical Ingredient (ICHQ7A) and contribute to the implementation of new REACH regulation,
- Application for registration of class III, implantable sterile Medical Device in Europe (CE Mark), Asia, South America and Middle Est.
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Virbac
- Quality Assurance Officer
Carros
2007 - 2008
Quality Assurance Officer - Virbac (-------
Contribute to implementation and support of GMP compliance for Vaccine and injectables with all production sites of
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VIRBAC Carros-France and especially with production managers,
- Partnership with Human Resources department for establishment of new employee process, GMP training and qualification of employees for operation in clean areas (answer to NCA inspection),
- Create of welcome process for new comers based on each manufacturing processes and environment for Virbac
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Virbac
- Quality Assurance Officer
Carros
2007 - 2008
Quality Assurance Officer - Virbac (-------
Contribute to implementation and support of GMP compliance for Vaccine and injectables with all production sites of
-
VIRBAC Carros-France and especially with production managers,
- Partnership with Human Resources department for establishment of new employee process, GMP training and qualification of employees for operation in clean areas (answer to NCA inspection),
- Create of welcome process for new comers based on each manufacturing processes and environment for Virbac
-
Virbac
- Quality Assurance Officer
Carros
2007 - 2008
Quality Assurance Officer - Virbac (-------
Contribute to implementation and support of GMP compliance for Vaccine and injectables with all production sites of
-
VIRBAC Carros-France and especially with production managers,
- Partnership with Human Resources department for establishment of new employee process, GMP training and qualification of employees for operation in clean areas (answer to NCA inspection),
- Create of welcome process for new comers based on each manufacturing processes and environment for Virbac
