Location: Neuchâtel
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 serve as the quality representative for day-to-day GMP activities and for major project-related deliverables.
Requirements
* Review and evaluate change requests per GMP requirements and internal procedures
* Act as the Quality partner for QC Laboratory projects and facility projects
* Ensure deployment and adherence to quality systems in line with regulatory expectations
* Oversee quality aspects during validation (plans, protocols, URS, risk assessments, etc.)
* Lead or review deviations and define CAPAs using tools like TrackWise
* Proactively communicate project activities, findings, and risks
* Prepare and approve revisions of controlled documentation
* Report 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 and 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
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