QMS Associate (80%)

The QMS Associate role at Proclinical involves supporting and enhancing the Quality Management System (QMS) at a biotechnology site in Solothurn. Proclinical is a leading life sciences recruiter dedicated to matching exceptional talent with top positions in the industry. The QMS Associate will play a crucial role in ensuring operational integrity and upholding the highest standards in pharmaceutical quality assurance. The main day-to-day responsibilities include coordinating and monitoring audit and inspection commitments, organizing site governance meetings, and supporting the Self-Inspection Program. The role also involves assisting with QMS processes such as deviations, CAPAs, change controls, and training assignments. Additionally, the QMS Associate will ensure accurate and compliant documentation of QMS activities using systems like TrackWise, Veeva, and myCIMS. Collaboration with cross-functional teams, including QA, QC, Manufacturing, and Engineering, is essential for maintaining compliance and timely completion of actions. To be considered for this role, candidates must have strong communication skills in English, both verbal and written. A proactive approach to managing assignments and responsibilities is crucial, as is the ability to work collaboratively across all levels of the organization. Familiarity with biotechnology API production and quality systems such as TrackWise, Veeva, or similar platforms is a plus. Candidates must also have the right to work in the location or hold an EU passport. Nice-to-have skills include familiarity with biotechnology API production and quality systems such as TrackWise, Veeva, or similar platforms. The role offers an opportunity to collaborate across various functions while fostering a culture of compliance. The team-oriented mindset and the ability to make technical decisions and solve problems with cross-functional teams are highly valued. What the role asks for: - Strong communication skills in English, both verbal and written. - The right to work in the location or hold an EU passport. - Self-motivated, with a proactive approach to managing assignments and responsibilities. - 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 (nice to have).