+20 years of experience in the life science industries (Medical Devices, Pharmaceuticals incl. APIs & excipients, related suppliers and IT service providers)
Profound expertise in the implementation and improvement of Quality and integrated Management Systems, SAP and MES templets and cloud services (all GxP-compliant)
Experience also includes Computerized System Validation including data governance, data integrity requirements and Audit Management
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- PhD in Organic Chemistry (1997)
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality Management Systems, System Implementation, CSV, Validation Documentation, Audits & Inspections, GxP, GAMP, ISO 9001, ISO 27001, ISO 14001, ISM / ITIL, Pharma & Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Validation Manager Master Data
Validation Manager for different corporate Master Data Management systems
Implementation, release and changes, data changes
Periodic Reviews
GxP Incidents, deviations, investigations etc.
Medical Devices Company, Germany
DMS Restructuring Manager
Migration of a eDMS to new structure
Validation Management
Pharmaceutical Company, Switzerland
CSV Manager (SAP & QMS)
Improvement of CSV framework and change management process
Revalidation of SAP Outbound Logistics
Consolidation of life cycle documents
Change Management
Validation of QMS
Medical Devices Company, Germany
FDA Inspection preparation
CAPA and Complaint Management
Presentations
Quality Oversight