Consultant CSV und Laborinformatik (m/w/d)
Core
Implementing technical and procedural adjustments for computerized systems in laboratory and production based on compliance gap analyses for Data Integrity and Annex 11.
Role type
Senior IC Quality & Compliance Consultant (CSV)
Builds
Remediation plans and system-level compliance measures for ~80 computerized systems
Domain
Pharmaceutical industry, Quality Management, Computerized System Validation (CSV)
Required skills
Computerized System Validation (CSV), GxP and non-GxP compliance, Gap analysis, Process mapping, System documentation, Project coordination
Preferred skills
Analytical measurement system software, Windows 10/11, Microsoft Office
Technologies
Windows 10/11, Microsoft Office
Responsibilities
Create remediation plans for Data Integrity non-GMP and Annex 11, Implement plans with lab and operations functions, Coordinate measures at system level, Report progress and status, Identify obstacles and escalate, Create and adapt system-specific and cross-system documentation, Implement CSV and IT guidelines
Seniority
Senior, hands-on IC