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Septodont
- Quality Produt Manager
Saint Maur des Fossés Cedex
2012 - maintenant
▪ Release of products: includes finished and semi-finished products, packaging and raw materials.
▪ Handle trouble-shoots manufacturing and QC issues
▪ Follow up on CAPA and change controls related to deviations
▪ Maintain QA documentation as appropriate
▪ Maintain GMP quality best practice and compliance within the department and the company
▪ Ensure environmental monitoring (pressures, temperatures, air flows, microbiological and particles) as well as water loops monitoring
▪ Follow up on customers complaints
▪ Manage a 18-persons team in charge of the:
Preparation of all documents needed for the release
In process controls and water loops sampling
▪ Coordinate and conduct internal audits
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Genus Pharmaceuticals
- Quality Assurance Officer
2009 - 2011
▪Quality assurance officer for contractors and partners located in Europe, Japan, Australia and USA:
▫Maintain and develop relationships with commercial contractors and licensing partners for specific projects
▫Handle trouble-shoots manufacturing and QC issues at contractors
▫Coordinate project management of compliance activities at selected manufacturers e.g. process validation, analytical method validation, stability trials, TSE statements, etc.
▫Participate to projects for new suppliers and new products
▪Quality systems coordinator:
▫Implement GMP quality best practice and compliance within the department and the company as a whole
▫Coordinate and conduct external audits and self-inspections,
Follow up on CAPA and maintain QA documentation as appropriate
▫Draft and track third party agreements
▫Coordinate and tracks documentation relating to on-going stability
▫Coordinate the complaints handling process
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Sanofi-Aventis
- Quality Manager - Management of Subcontractors
Paris
2006 - 2009
•Define strategies, rules and directives for the quality management of the subcontractors in accordance with the quality program of Sanofi Aventis
• Give quality expertise and support to the entities that work with subcontractors
• Coordinate audit programs and implement new regulations regarding drug products and active pharmaceutical ingredients
• Evaluate the critical risks in coordination with the entities, perform risk assessment by evaluating the consistency of the data and of the action plan and follow the actions plans implemented
• Audit subcontractors in accordance with the Sanofi Aventis group policy
• Ensure quality and regulatory compliance of subcontractors
• Collaborate with other departments : development, regulatory affairs and supply chain, to investigate quality issues, implement action plans and face out-of-stock situation
• Create tools to help subcontractors be compliant with directives : annual product review, gap analysis, bulk transport validation
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Sanofi-Pasteur
- Batch release deputy
Lyon
2001 - 2005
• Review and approve technical specifications and approbation of analytical data
• Release the intermediary and finished products batches : manage a products portfolio (flu vaccines, measles/rubella combined vaccines, hepatitis A/typhoid combined vaccines, tuberculosis vaccines, rabies vaccines, haemophilus influenzae type b vaccine combined to diphtheria/tetanus/pertussis, solvents)
• Evaluate and assess non-conformities, work with all relevant departments to investigate quality issues and follow actions plans
• Approve and manage documents mandatory for the release of vaccines batches for the French and foreign countries health authorities
• Manage a 4-persons team in charge of the preparation of all documents needed for the release
• Coordinate work and communication between the Sanofi Pasteur batch release department and the subcontractors in charge of manufacturing vaccines
• Participate to pre-inspections meeting and regulatory inspections
