QA Specialist (Computerized Systems & GxP) | Biologe (m/w/d)
Charles River Laboratories Germany GmbH
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
Additional
- Not specified
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