Ing. Eleonore Hirschfeld

Responsible for • supplier management at 4 Alcon locations (Alcon Grieshaber AG Schaffhausen, Wave Light GmbH Erlangen, Pressath and Teltow) • new supplier qualification • creation, negotiation and administration of quality assurance agreements with GxP supplier and service providers • supplier audits (Alcon certified auditor) • leading of supplier auditor team • training and qualifying auditors

Responsible for • leadership, direction and support to QA Release Officer, • product release in accordance with registered specifications and local/international regulations, • elaboration QA release relevant SOP's, • training of employees on GMP and GDP requirements for production orders

Responsible for • implementation and execution of internal audits program (Alcon Grieshaber AG Schaffhausen, Wave Light GmbH Erlangen, Pressath and Teltow) according to requirements and regulations, • performing supplier audits, • local facilitator for external audits

Data Manager in der Qualitätssicherung: Deviation Handling CAPA Organisieren und Administrieren von Management Review Product Quality Review Change Control Site Quality Risk Assessment Einführung eines elektronischen Systems (Track Wise) für Deviation und CAPA Handling (Projektleitung am Standort, SOP Schreiben, Mitarbeiter trainieren) Co-Auditor bei den internen Autits Vorbereitung und aktive Mitarbeit bei den externen Audits und Inspektionen

Durchführung und Mitarbeit an verschiedenen Projekten wie z.B. Sprühschattenbestimmung, Reiningungsvalidierung.

Durchführung verschiedener Projekte wie z.B. Device History File Review/Update

Betriebstechnik