Project title:
Senior Quality Assurance Specialist m/f/w
Type of employment:
Payroll
Industry:
Biotech
Skills:
Downstream, CAPA, Change management
Project start:
Project duration:
3 months
Location:
1800 Vevey, Switzerland
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