Mag. Alexandra Reindl

Facility Quality Management Representative at the Baxalta Plant Orth/Donau Overall Quality Management responsibility for manufacuturing and control of clinical and commercial products

Leitung der Bereiche Quality in Operations, Quality System Deployment (Sterility Assurance, Change Control, Document Management, Annual Product Review & Site Master File), Product Release, Exception Management

Leitung der Bereiche Quality in Operations, Quality Validation, Sterility Assurance, Change Control, Material Management

Quality Support im Rahmen von Projekten zur Produktentwicklung sowie Implementierung neuer Produkte und Technologien; Projektleitung; Planung von Projekten aufgrund von Quality Anforderungen; zeitliche und inhaltliche Abstimmung von GMP und regulatorischen Aktivitäten im Rahmen von Projekten; Verbesserung von Qualitätsstandards sowie Pflege und Weiterentwicklung von QS/GMP-Systemen.

Coordination and Supervision of GMP Audit Organization Vienna Coordination of Co Auditor Team Control of compliance to national and international regulations and guidelines

Control of compliance to national and international regulations and guidelines Preparation and organization of inspections by 2nd/3rd parties Organization and control of the audit program Preparation, organization and performance of trainings Performance of audits

Conducting assessments Improve quality/regulatory compliance Provide support in preparing for regulatory inspections

Implementation and maintenance of OOS-System Deviation Management

Deviation Management