QA Deviation Management Specialist
On-site · Allschwil, Basel-Landschaft, Switzerland
Job Summary
QA Deviation Management Specialist within Thermo Fisher Scientific's Clinical Trials Division reviews and approves deviations, complaint investigations, CAPAs, and effectiveness checks to maintain quality and compliance. Responsibilities include mentoring investigators to improve investigation quality and CAPAs, coordinating investigation approvals within required timelines (including support for batch release activities), analyzing data to improve Quality KPI, participating in Practical Process Improvement (PPI) initiatives and other quality/efficiency projects, supporting internal and client audits and regulatory inspections, and delivering training. Requires a degree or relevant experience in the pharmaceutical/life sciences field, knowledge of cGMP and regulatory requirements, 2+ years in deviation investigations and quality systems, and proficiency in German and English; strong communication, organization, and the ability to work independently and within cross-functional teams. The role is based at the Allschwil site in Switzerland, supporting clinical trials operations across the pharma services spectrum, including manufacturing support, packaging, labeling, distribution, and lifecycle quality management.
Required Qualifications
- Degree or relevant experience in the pharmaceutical industry, Quality Control/Quality Assurance, medication handling, life sciences or related field
- Minimum 2 years of experience in deviation investigations, CAPA, change control, and root cause analysis
- Minimum 2 years of experience with quality management systems and documentation (e.g., TrackWise or equivalent)
- B2 or higher level in German and English
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