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.
  

If you are having difficulty in applying or if you have any questions, please contact Ria Tailor at r.tailor@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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