Requirements: English
Company: Swisslinx
Region: Neuchtel , Neuchtel
Location: Neuchtel
Workload: 100%
Start: ASAP
Duration: Until 21/11/2025 with chances for extension
Job description As a QA Expert, you''ll report directly to the QA Manager and ensure compliance, validation, and quality oversight across engineering and QC laboratory projects. You''ll be both the quality representative for day-to-day GMP activities and for major project-related deliverables.
Requirements - Reviewing and evaluating change requests per GMP requirements and internal procedures
- Acting as the Quality partner for QC Laboratory projects and facility projects
- Ensuring deployment and adherence to quality systems in line with regulatory expectations
- Overseeing quality aspects during validation (plans, protocols, URS, risk assessments, etc.)
- Leading or reviewing deviations and defining CAPAs using tools like TrackWise
- Proactively communicating project activities, findings, and risks
- Preparing and approving revisions of controlled documentation
- Reporting critical issues to functional and senior management
Competences - Bachelor''s or Master''s degree in Engineering, Biotechnology, Pharmacy or Quality Management
- 3-5 years of experience in a GMP environment (preferably biotech/pharma)
- Solid knowledge of FDA, EMA, ICH, ISO standards, and data integrity principles
- Experience with QC equipment, CSV, and validation processes
- Affinity for digital tools and automated systems
- Excellent communication skills in French and strong English (spoken and written)
- Organized, proactive, pragmatic, and solution-oriented
- Comfortable working cross-functionally and in a fast-paced setting
Compensation benefits - A long-term contract with strong potential for extension
- The chance to work on high-impact projects in a world-class biotech environment
- Supportive recruitment process and guidance from our team throughout