2012 - maintenantHandle the quality-related aspects for hormonal products from the development to the launch of the product and contribute to the implementation, maintenance and improvement of the Quality Management System (QMS)
- Qualification of APIs suppliers and Contract Manufacturing Organisations (CMO), monitoring of their compliance by regular follow-up and GMP audits
- Review and approval of batch-related documents ;
- Coordination of launches of new products, in collaboration with both internal and external partners, including implementation of Quality/Technical Agreements
- Supervision of GMP and quality-related requirements (on-going stability studies, PQR...) ;
- Support to the customers / distributors / affiliates in case of quality-related requests/issues ;
- Coordination of quality issues and related investigations on complaints and deviations
- Involvement in the implementation and maintenance of the documentation system (SOPs) and in the preparation of inspections and internal audits
- Involvement in the implementation of stability studies to assess the impact in case of temperature excursion
Lyon2006 - 2012Quality Assurance Compliance Supervisor (2006 – 2010, team of 2 persons)
Quality Assurance Manufacturing Associate Manager (2010 – 2012, team of 3 persons)
Release aseptically filled or sterilized batches after assuring that they comply with all GMP standards – 21 CFR Part 210 and 211, Aseptic Guideline and Eudralex – and specifications.
- Team management ;
- Review and approval of procedures (SOPs) and Master Batch Record (MBR) ;
- Review and approval of deviations and Out of Specifications (OOS) reports
- Review of commercial, validation and clinical batch records
- Investigation and follow-up in case of customers complaints and suppliers complaints
- Evaluation and approval of internal and suppliers change requests
- Involvement in Product Quality Review (PQR) and Quality System Review (QSR)
- Approval of initial and routine validation protocols and reports (e.g. autoclave, HVAC, visual inspection machine, process, cleaning, media fill and sterilisation)
- Performance of internal and supplier audits, and participation in Health Authorities inspections (e.g. FDA, Swissmedic, ANVISA, Canadian inspection)
- Involvement in technical, quality and improvement projects such as :
o Simplification of the change control process,
o Re-definition of the cleaning validation policy and the Media fill policy,
o Launch of new commercial or clinical product,
o Review of the environmental monitoring,
o Standardization in the way of handling tasks,
o Review of the training process of the operators in charge of the visual inspection,
o Implementation of two control levels for the batch record review,
o Actions implementation to be compliant with Annex 1 to EU-GMP guide
SpineVision S.A.
- Quality Assurance Assistant
2004 - 2005Assure the compliance of the quality system of the company and its sub-contractors with the American and European regulation requirements - 21 CFR Part 820: Quality System Regulation (QSR), 93/42/CE directive relative to CE Marking, and ISO13485:2001 standard.
- Evaluation of internal and sub-contractors quality systems towards QSR requirements and definition of appropriate action plans
- Performance of internal and sub-contractors audits, and follow-up of action plans
- Review and approval of design and process validation protocols and reports
- Re-definition of the sub-contractors qualification and the change management systems
Rhodia Organique
- Trainee Quality Engineer
Courbevoie2003 - 2004In conformity with French regulations for workshops producing raw materials (API and excipients) for pharmaceutical use, submit the registration files to the French Authorities AFSSAPS, ex-ANSM) and apply the appropriate Good Manufacturing Practices (GMP) - ICH Q7A and IPEC.
