QMS Quality Associate: Governance & Audit Support (80%)

Randstad Switzerland; Luterbach; Hybrid; CHF 60.000 - 90.000; Teilzeit

Zusammenfassung

Randstad Switzerland partners with a leading biotechnology company in Solothurn to hire a Quality Associate (80% workload) on a temporary contract. You will support QMS operations, coordinate governance activities, and help sustain inspection readiness without taking full ownership.

In this role you will collaborate with QA, QC, Manufacturing and Engineering, maintain TrackWise, Veeva and myCIMS records, and contribute to a strong culture of compliance.

Qualifikationen

• Good communication skills in English, both written and spoken.
• Knowledge of biotechnology API production.
• Understanding of GMP regulations and QMS.
• Self-driven with ownership of assignments.
• Ability to work with cross-functional teams and value input from others.
• Ability to drive discussions to solve problems.

Aufgaben

• Coordinate and monitor audit and inspection commitments with timely closure.
• Organize meetings with SMEs to review actions and updates.
• Support governance forums for deviations, change controls, CAPAs and QMS reviews.
• Plan and track Self Inspection Program activities with SMEs.
• Maintain tools and trackers for inspection readiness and compliance monitoring.
• Support QMS processes including deviations, CAPAs, change controls, and training assignments.

Kenntnisse

English communication

API production knowledge

GMP & QMS understanding

Self-driven

Teamwork

Cross-functional collaboration

Prioritization

Flexibility

Decision making

Tools

TrackWise

Veeva

myCIMS

Jobbeschreibung

Randstad Switzerland partners with a leading biotechnology company in Solothurn to hire a Quality Associate (80% workload) on a temporary contract. You will support QMS operations, coordinate governance activities, and help sustain inspection readiness without taking full ownership.

In this role you will collaborate with QA, QC, Manufacturing and Engineering, maintain TrackWise, Veeva and myCIMS records, and contribute to a strong culture of compliance.