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As QA Coordinator, the role provides administrative support to our Manufacturing QA team, helping ensure smooth and compliant execution of GMP (Good Manufacturing Practice) and medical device quality activities. The position supports both clinical and commercial products, including combination products. Success in the role comes from being structured, detail-oriented, and motivated by getting quality documentation and coordination right the first time.
Job Responsibility:
Support batch release activities by preparing checklists and documentation packages
Track and oversee incoming quality items from Contract Manufacturing Organizations (CMOs) (e.g., deviations, change requests, complaints)
Log and maintain quality records in our electronic document management system (EDMS), Veeva
Draft, update, and route SOPs (Standard Operating Procedures), Quality Agreements, and other controlled quality documents
Support preparation and follow-up of internal and external audits within GMP, GDP (Good Distribution Practice), and selected device requirements
Coordinate day-to-day administrative QA tasks in close collaboration with the QA colleagues to help maintain compliant processes and timely execution
Requirements:
Bachelor’s degree within life science/pharmacy (or similar), Laboratory Technologist/Lab Technician, or equivalent experience from a QA/GMP environment
Experience from quality assurance or GMP operations in pharma and/or medical device industries (preferred)
Strong organizational skills and attention to detail
able to manage multiple parallel tasks
Strong English written and verbal communication skills (incl. clear, concise documentation)
Familiarity with quality systems and documentation practices (e.g., Veeva) and GMP requirements
Team-oriented and proactive, with sound judgement and a compliance mindset