QMS Associate (80%)

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

Driven to uphold the highest standards in pharmaceutical quality assurance? Step into this role where your expertise ensures operational integrity.

Proclinical is seeking a QMS Associate to support and enhance the Quality Management System at a biotechnology site in Solothurn. In this role, you will assist with core quality activities, coordinate governance processes, and contribute to maintaining inspection readiness. This position offers an opportunity to collaborate across various functions while fostering a culture of compliance.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

Audit and Inspection Support:

• Coordinate and monitor audit and inspection commitments to ensure timely closure and proper documentation.
• Organize and facilitate meetings with subject matter experts (SMEs) to review action status and maintain alignment on deliverables.

Site Meeting Governance:

• Schedule and manage logistics for site governance meetings, including agenda preparation and documentation of decisions.
• Support forums related to deviations, change controls, CAPAs, and other Quality Management System (QMS) review boards.
• Contribute to optimizing governance meetings to align with site objectives.

Self-Inspection Program Execution:

• Assist in planning, implementing, and tracking the Self-Inspection Program, ensuring timely documentation and follow-up of observations.
• Maintain tools and trackers to support inspection readiness and compliance monitoring.

QMS Administration and Operational Support:

• Support QMS processes such as deviations, CAPAs, change controls, training assignments, and quality risk management.
• Collaborate with cross-functional teams (QA, QC, Manufacturing, Engineering) to ensure compliance and timely completion of actions.
• Assist with KPI reporting and monitoring.

Documentation and Data Management:

• Ensure accurate and compliant documentation of QMS activities in systems like TrackWise, Veeva, and myCIMS.
• Maintain logs, trackers, meeting minutes, dashboards, and metrics related to QMS processes.
• Identify opportunities to streamline QMS processes and improve documentation quality.

Key Skills and Requirements:

• Strong communication skills in English, both verbal and written.
• Ability to work collaboratively across all levels of the organization and with multiple functions.
• Self-motivated, with a proactive approach to managing assignments and responsibilities.
• Team-oriented mindset, valuing input from colleagues and peers.
• Confident in making technical decisions and solving problems with cross-functional teams.
• Strong organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously.
• Familiarity with biotechnology API production and quality systems such as TrackWise, Veeva, or similar platforms is a plus.