Kwaliteitsspecialist

For one of our clients in the pharmaceutical sector, we are looking for an experienced Senior Quality Engineer. In this role, you will be responsible for ensuring and improving quality, compliance, and process optimization within a technical environment focused on production, utilities, and laboratories.
Details   32-40 hours per week
Duration: 12 months
Responsibilities   Responsible for quality and GMP-related aspects within maintenance, engineering, and qualification activities
Lead and support continuous improvement initiatives within the organization
Act as a subject matter expert in validation activities
Optimize and align internal processes and collaboration between teams
Implement and monitor performance and KPI systems
Safeguard compliance within GMP regulations
Support CAPAs, deviations, events, and their follow-up
Conduct and follow up on internal audits
Advise on Process Excellence in maintenance and project execution
Requirements   Bachelor's degree in Mechanical Engineering, Electrical Engineering, Installation Technology, or Process Engineering
4-8 years of experience as a Quality Engineer or in a similar role within a GMP environment

Experience with Process Excellence methodologies (e.g., Lean Six Sigma; Greenbelt is preferred)
Knowledge of GMP, validation, and qualification processes (including Annex 11)
Familiar with relevant regulations and guidelines (e.g., FDA, ICH, ISPE)
Strong communication skills and analytical mindset
Proactive, independent, and able to handle changing priorities

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