QMS Associate (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

For our client, a leading biotechnology company based in Solothurn, we are seeking a Quality Associate (80% workload) for a temporary mission supporting QMS operations.

In this role you will contribute to maintaining and strengthening our client's Quality Management System. You’ll support core quality activities, help coordinate routine governance processes, and assist in maintaining inspection readiness. You will collaborate with various site or global functions to ensure smooth execution of essential quality tasks. This position allows you to play an important part in sustaining a strong culture of compliance without carrying full ownership of operational responsibilities.

General Information

• End date: 28/02/2027
• Extension: possible, to be discussed
• Contract type: temporary contract via Randstad (employment)
• Workplace: Luterbach, Solothurn
• Home office: 1 day/week

Tasks & Responsibilities

Audit and Inspection Support

• Coordinate and monitor audit and inspection commitments to ensure timely closure and proper documentation in line with QMS requirements.
• Organize and facilitate meetings with SMEs to review action status, gather updates, and maintain alignment on deliverables.

Site Meeting Governance

• Schedule and manage logistics for site governance meetings (e.g., Investigation Review Board), including agenda preparation, pre read collection, and documentation of decisions.
• Support governance forums related to deviations, change controls, CAPAs, and other QMS review boards to ensure consistent application of company standards.
• Contribute to improving and optimizing governance meetings in line with site objectives

Self Inspection Program Execution

• Assist in planning, implementing, and tracking the Self Inspection Program, including scheduling activities with SMEs and ensuring timely documentation and follow up of observations.
• Maintain tools and trackers supporting inspection readiness and compliance monitoring.

QMS Administration & Operational Support

• Support QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management in accordance with company procedures.
• Collaborate with cross functional stakeholders (QA, QC, Manufacturing, Engineering, etc.) to ensure compliance and timely completion of required actions.
• Support on KPIs reporting and monitoring.

Documentation & Data Management

• Ensure accurate and compliant documentation of QMS activities in systems such as TrackWise, Veeva, and myCIMS.
• Maintain logs, trackers, meeting minutes, dashboards, and metrics related to QMS processes and governance activities.
• Identify opportunities to streamline QMS processes, improve documentation quality, and enhance visibility of compliance commitments.

Your Profile

• Good communication skills in English, verbally and written.
• Knowledge of biotechnology API production.
• Understanding of GMP regulations and QMS.
• Self-driven and take ownership and responsibility for own assignments.
• Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers.
• Able to drive discussion to solve problems with cross functional teams.
• Be confident in making technical decisions. In addition, able to prioritize tasks, be flexible and able to keep many activities running at a time.