Senior Quality Assurance Specialist m/f/w

vor 1 Woche

Vevey, Waadt, Schweiz Aristo Group Vollzeit

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

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