Mes compétences :
Audit
Quality Assurance
Certification Green Belt LEAN
LIMS
ICH
Change Management
Trackwise
Deviation Management
Analytical chemistry
Entreprises
Baxter International
- Quality Assurance Expert
Maurepas2011 - maintenant• write impact assessments linked to production/metrology deviations, take part in investigations and implementation of preventive/corrective actions.
• take part in change control system: write impact assessments, approve action plans and ensure the follow-up of actions implementation, initiate/approve Change Proposal for documentation.
• review and approve batch records and development, (re)validation, (re)qualification protocols.
• be a QA support during internal and external audits.
• take part in development of QA specialists on technical points
• take part in daily interdepartmental QIT (maintenance, QA, metrology, production, automation) in order to make decisions on deviations met during the process and on associated strategies.
ALK Abello
- System Quality Assurance Assistant
2011 - 2011• be the QA contact for analytics, stability and R&D topics.
• take part in equipment qualification/process validation strategies and approve associated documents.
• approve work instructions and take part in their improvement.
• analyze non-conformities and help operational departments to define and implement preventive / corrective actions.
• perform internal/external audits and ensure the follow-up of action plans.
GlaxoSmithKline
- Quality Assurance Engineer
Marly-le-Roi 2010 - 2010• ensure answers and follow-up of supplier and customer complaints (international contacts such as EMEA, Australia, Japan and USA).
• write specifications for supplier; work with suppliers during quality projects.
• take part in redaction of periodic product reviews and quality indicators.
• take part in and/or lead quality projects (follow-up of deviations, continuous improvement).
