Coporate Qms Specialist (Efor-Cvo)
Current• Drives, executes and supports consistent quality processes with external customers (Lilly, Blue Earth Diagnostics and GE Healthcare) for document management and related communication. Single point of contact for quality.• Drives and supports the lifecycle of GxP documents and records (maintenance, storage, retention, archiving, disposition)• Provide assistant support for the AAA Head of QMS.• Assures consistent processes of global change control. • Supports applicability assessment of documents. Contributes to preparation of implementation strategies and communicates them accordingly.• Participate to project for development and implementation of new QMS IT tools• Contributes to coordination and execution of QMS IT tools trainings.• Contributes to team communications and related tools (SharePoint, Ennov, etc.)• Works with the colleagues to ensure efficient operational support.• Operates in alignment with AAA procedures and contributes improvements for the current processes. • Provides other relevant metrics and other appropriate reports as needed. Additional tasks/projects- Act as a key user in the CSV project related to the QMS (new digitized modules to be implemented: Deviation, Change Control, OOS, OOT, CAPA, E-learning & complaints)- Coordinate, support and train sites in relation to the new modules implemented -Prepare documents required for training and use of implemented modules - Lead and ensure a consistent testing process for new modules- Participate in the preparation of URS and FRA for new modules - Ensure compliance with customer specifications and implementation by the development team;- Prepare documents required for training and use of new modules.- Coordinate, support and train the site during the KQI reporting process.- Drive and ensure a consistent technical complaints process for the country without a Quality Assurance representative.
