Manufacturing Process Investigation

Vor 4 Tagen

Lausanne, Waadt, Schweiz cvo europe Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

In 12 years, the
Efor Group
has reached the leading position in Life Sciences consulting. Our ambition is to build a global leading position in our market by 2028. In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers diversify and grow through the work of our consultants and the technical expertise of our Technical Department.

CVO-EUROPE SA
(part of the Efor Group), based Avenue de l'Etang 61 – 1219 Châtelaine, is recruiting and manage client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates

Your responsibilities:

  • Manage deviations involving equipment, products, and materials within the quality system (TrackWise)
  • Conduct root cause investigations using Six Sigma methodologies, DMAIC, Ishikawa, 5M, contradiction matrix (on the shop floor and through automated systems)
  • Define, implement, and monitor corrective and preventive actions (CAPA), including business case development and planning with relevant stakeholders
  • Write clear, structured, and scientifically sound investigation and impact assessment reports
  • Present findings to management and escalate critical issues when required
  • Monitor and drive internal KPIs for deviations and CAPA in collaboration with your manager
  • Depending on complexity, lead cross-functional investigation teams or facilitate workshops/brainstorming sessions

Your profile:

  • Strong knowledge of biotechnology processes (DSP), automated operations, and industrial data management systems
  • Good understanding of cGMP standards and associated regulations
  • Ability to translate complex technical issues into concise and comprehensible reports
  • Meticulous, resilient, pragmatic, structured, and rigorous approach to work
  • Willingness and ability to work collaboratively with diverse teams (Production, QA, QC, Engineering, EHS, etc.)
  • Fluency in French and a good command of English (full fluency is a strong asset)

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