Vanessa BARTHOLOMEY

En résumé

Entreprises

• 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.

• 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.

• 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

Formations

• Fac De Médecine

  Nice 2004 - 2006 Master II
  
  : Master II Degree : ``Quality, Security, Risk and Management Engineering''

• Fac De Médecines

  Nice 2002 - 2003 Licences

• Fac Des Sciences

  Nice 2000 - 2002 Drug Bio
  
  E6(R2) / Data Integrity (Regulatory Partner- Boston), GMP meets Development (ECA Academy - Germany),

Réseau

Pas de contact professionnel