QA Specialist (Computerized Systems & GxP) | Biologe (m/w/d)

Charles River Laboratories Germany GmbH

Erkrath, Nordrhein-Westfalen, Deutschland
Published Sep 15, 2025
Full-time
No information

Job Summary

This role is for a QA Specialist focusing on computerized systems and GxP compliance within a global life-science company. The successful candidate will ensure that computerized systems meet global regulatory requirements and internal standards, overseeing their implementation and maintenance. Key responsibilities include supporting computer system validation (CSV) and equipment qualification projects, conducting risk-based inspections, and analyzing quality-related KPIs. The specialist will also contribute to continuous process optimization, address compliance gaps, and support the QA team with regulatory queries. This position offers a chance to make a significant impact on global health and well-being within a collaborative environment.

Required Skills

Education

Completed scientific, technical, or comparable university degree

Experience

  • 1-5 years of professional experience in Quality Management within a GxP-regulated environment (e.g., Pharma, Biotech, Contract Research)
  • Experience with computerized quality systems (e.g., TrackWise, Veeva or comparable)
  • Familiarity with regulatory requirements (FDA, EMA, GxP) and quality systems

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified