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F. Hoffmann-La Roche AG
Quality Management System Process EngineerF. Hoffmann-La Roche AG • mississauga, peel region, Canada
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Quality Management System Process Engineer

Quality Management System Process Engineer

F. Hoffmann-La Roche AG • mississauga, peel region, Canada
4 hours ago
Job description

Data analytics and process engineering define this QMS Process Engineer role at Roche in Mississauga. Apply digital tools within regulated Pharma Development operations.

As a QMS Process Engineer, you will support operational excellence across Critical-to-Quality ecosystems. You will design workflows, connect automation tools, analyze quality data, and embed regulatory expectations into processes. The position supports inspection readiness and QMS evolution across global operations.

Key Responsibilities:

  • Design and optimize data-execution workflows with business partners
  • Connect AI and automation tools across linear workflows
  • Analyze raw data for trends, patterns, and systemic findings
  • Embed GxP regulations and CtQ principles into processes
  • Support inspections and monitor process performance indicators

Requirements:

  • Bachelor’s degree or equivalent practical experience
  • At least five years of relevant professional experience
  • Experience in regulated GxP environments
  • Knowledge of GCP, GVP, IVD, or MD development
  • Data analytics and quality data storytelling experience

Bring QMS expertise, digital literacy, and regulatory process improvement skills to Roche’s Mississauga operations.

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Quality Management System Process Engineer • mississauga, peel region, Canada