QMS Associate / QMS Associate

Quality Management System Associate Opportunity

Are you dedicated to maintaining the highest standards in pharmaceutical quality assurance? Join us in a pivotal role where your expertise will ensure operational integrity. Proclinical is seeking a QMS Associate to support and enhance the Quality Management System at a biotechnology site in Solothurn. In this position, you will engage in core quality activities, coordinate governance processes, and contribute to maintaining inspection readiness, all while promoting 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 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 to ensure timely documentation and follow-up on observations.
  • Maintain tools and trackers to support inspection readiness and compliance monitoring.
• QMS Administration and Operational Support:
  • Support QMS processes including 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.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional talent and matching them with outstanding positions globally. Proclinical is acting as an Employment Agency in relation to this vacancy.

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