Senior Quality Assurance Specialist m/f/w

vor 1 Woche


Vevey, Schweiz Aristo Group Vollzeit

Project title:Senior Quality Assurance Specialist m/f/wType of employment:PayrollIndustry:BiotechSkills:Downstream, CAPA, Change managementProject start:Project duration:3 monthsLocation:1800 Vevey, SwitzerlandTasks: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 experience3–5 years of experience in a biotech/pharmaceutical GMP manufacturing environment (manufacturing, quality, or support functions)Confident use of MESFrench and English language skillsAutonomyStrong written and oral communication skillsLeadership



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