Quality Assurance Expert

Summary: The Quality Assurance Expert role involves ensuring compliance, validation, and quality oversight in engineering and QC laboratory projects. Reporting to the QA Manager, the expert will act as a quality representative for daily GMP activities and major project deliverables. The position requires a proactive approach to communication and documentation, with a focus on regulatory adherence and quality systems. This is a long-term contract with potential for extension in a dynamic biotech environment.

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