Suresnes
- Treatment of deviations (non-conformities) declared by all the services of the industrial site, by putting in place the appropriate action plans and monitoring the completion of the latter until closing;
- Management and monitoring of CAPA (corrective actions / preventive actions that can be carried out in the long and medium term);
- OOS / OOT processing (routine and stability);
- Drafting, verification and approval of the Masters of Manufacturing and Packaging;
- Processing, management and monitoring of changes (Change Controls);
- Calculation and valuation of the costs related to the non-quality of the site (CNQ);
- Product manager (preparation, organization, management, coordination and monitoring of new products to be hosted by the site);
- Qualifications and validations of equipment / processes;
- Verification, preparation and submission of lots for pharmaceutical release;
- Management and processing of customer and supplier complaints;
- Annual product reviews (PQR);
- Conducting quality surveys and internal audits within the different production units;
- Drafting and updating the SOPs relating to the quality management system and guaranteeing
Their applications;
- Monitoring compliance with GMP and internal quality procedures;
- Participation in the preparation of external audits in the framework of inspections by
Supervision and audits carried out by the principal laboratories;
- Continuous improvement by looking for new areas of improvement and development of these in consultation with the managers of all the services of the industrial site;
- Efficient presence in the field to ensure continuous production support in compliance with quality standards and standards;
-Analysis of the performance of the different departments within the production site;
Mes compétences :
Lean manufacturing
Lean Office
Gestion de Production
Gestion de stock
Gestion de Projet
Supply Chain
Jidoka
Iso 9001 v2008/v2015
Iso 14001
Iso 22001
Ohsas 18001
Management des systèmes documentaires
Qualification des équipements et procédés
Métrologie
Audit des suppliers et prestataires
Formateur BPF/BPL
HACCP
Language Visuel Basic
Techniques d'analyse physico-chimique
Techniques d'analyse bio/micro biologique
Iso 17025
Mise en place et pilotage des systèmes de manageme
Qualité fournisseur
Management et traitement des anomalies/CAPA/Chang
