Quality Assurance Expert

Summary: The Quality Assurance Expert will report to the QA Manager, ensuring compliance and quality oversight in engineering and QC laboratory projects. This role involves acting as the quality representative for daily GMP activities and major project deliverables. The position requires a proactive approach to communication and quality management within a fast-paced biotech environment. The contract is long-term with potential for extension until November 2025.

Key Responsibilities:

• 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

Key Skills:

• 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

Salary (Rate): undetermined

City: Neuchâtel

Country: Switzerland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other