Senior Quality Assurance Specialist m/f/w

Type of employment: Payroll

Industry: Biotech

Skills: Downstream,CAPA,Change management

Project start: 1.12.2025

Project duration: 3 months

Tasks:

• Manage deviations occurring in Downstream manufacturing suites for multiple products within the quality system (TrackWise) in a timely manner.
• Evaluate impacts on equipment, product, and materials with support from relevant experts.
• Conduct root cause investigations using Six Sigma methodologies (DMAIC, Ishikawa diagram, 5M, contradiction matrix, etc.), including data collection and analysis from automated systems and on-the floor (GEMBA).
• Identify and implement corrective and preventive actions (CAPA), including preparation of business cases and planning with stakeholders.
• Write comprehensive and scientifically structured investigation and impact assessment reports.
• Present findings and escalate blocking points to the line manager when necessary.
• Monitor and control internal deviations and CAPA KPIs in collaboration with the line manager.
• Lead cross-functional investigation teams, workshops, and brainstorming sessions depending on deviation complexity.

Qualifications:

• Bachelor’s or Master’s degree in Engineering (Chemical, Biotechnology) or equivalent experience
• 3–5 years of experience in a biotech/pharmaceutical GMP manufacturing environment (manufacturing, quality, or support functions)
• Confident use of MES
• French and English language skills
• Autonomy
• Strong written and oral communication skills
• Leadership