QMS & Compliance Specialist (Biotech)

Proclinical; Bezirk Solothurn; Vor Ort; CHF 70.000 - 100.000; Vollzeit

Zusammenfassung

Proclinical is seeking a QMS Associate to support the Quality Management System at a biotechnology site in Solothurn, Switzerland. You will assist core quality activities, coordinate governance processes, and contribute to inspection readiness while collaborating across QA, QC, Manufacturing and Engineering teams.

The role requires strong English communication, proactive organization, and the ability to operate in a cross-functional environment.

Qualifikationen

• Experience supporting audits and inspections within a regulated environment.
• Familiarity with QMS processes such as deviations, CAPAs, change controls.
• Ability to collaborate across QA, QC, Manufacturing, Engineering and other functions.
• Strong documentation and data management skills in quality systems.

Aufgaben

• Coordinate and monitor audit and inspection commitments to ensure timely closure and proper documentation.
• Organize and facilitate SME meetings to review action status and maintain alignment on deliverables.
• Schedule and manage site governance meetings, including agenda preparation and documentation of decisions.
• Support forums related to deviations, change controls, CAPAs, and QMS review boards.
• Assist in planning and tracking the Self-Inspection Program and maintain readiness trackers.
• Assist with KPI reporting and monitoring and ensure timely completion of actions.

Kenntnisse

Audit & Inspection

QMS Administration

Cross-functional collaboration

Documentation management

Organizational skills

Tools

TrackWise

Veeva

myCIMS

Jobbeschreibung

Proclinical is seeking a QMS Associate to support the Quality Management System at a biotechnology site in Solothurn, Switzerland. You will assist core quality activities, coordinate governance processes, and contribute to inspection readiness while collaborating across QA, QC, Manufacturing and Engineering teams.

The role requires strong English communication, proactive organization, and the ability to operate in a cross-functional environment.