)
)
Quality Associate QMS (M/F/D)
Tasks:
Independently manage QMS activities, including:
Deviations
Change Controls
CAPA management (initiation, follow-up, effectiveness checks)
Ensure compliance with GMP and US regulatory requirements
Actively contribute to the continuous improvement of quality systems
Prepare, support, and moderate QMS-related meetings, providing clear insights and recommendations
Plan, conduct, and follow up on internal audits and inspections
Support regulatory inspections and ensure inspection readiness
Define, track, and analyze QMS KPIs (e.g., deviations, CAPAs) using Power BI or Tableau
Collaborate cross-functionally with stakeholders to maintain a robust quality culture
Qualification:
3–5 years of experience in Quality Assurance within a GMP-regulated pharmaceutical environment
Proven hands-on experience with QMS (mandatory)
Ability to work independently and autonomously
Experience with TrackWise oder Veeva (plus)
Solid understanding of US GMP regulations
Strong analytical mindset with experience in data-driven quality metrics
Structured, proactive, and solution-oriented working style
English (business fluent), German (plus)
Requirements:
Start: asap
Duration: 31.12.2026
Capacity: 80% (4 days/week – 3 on-site, 1 remote)
Location: Solothurn, Switzerland
)