Support the engine of compliance that keeps pharmaceutical quality running flawlessly.
Proclinical is seeking a Quality Assurance Associate to support and enhance the Quality Management System at a pharmaceutical site in Solothurn, Switzerland. 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:
- Support Quality Management System (QMS) processes, including deviations, CAPAs, change controls, training assignments, and quality risk management.
- Collaborate with cross-functional teams such as QA, QC, Manufacturing, and Engineering to ensure compliance and timely completion of actions.
- Assist in reporting and monitoring key performance indicators (KPIs) and support inspection readiness efforts.
- Schedule and manage logistics for site governance meetings, including agenda preparation, pre-read collection, and documentation of decisions.
- Contribute to governance forums related to deviations, change controls, and CAPAs, ensuring consistent application of standards.
- Maintain accurate documentation of QMS activities in systems like TrackWise, Veeva, and myCIMS.
- Manage 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 compliance visibility.
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, including engineering, automation, validation, and manufacturing.
- Self-driven with a proactive approach to assignments and responsibilities.
- Team-oriented mindset with openness to input from colleagues and peers.
- Confidence in making technical decisions and driving discussions to resolve issues with cross-functional teams.
- Strong organizational skills with the ability to prioritize tasks and manage multiple activities simultaneously.
- Knowledge of biotechnology API production and familiarity with quality systems and tools such as TrackWise, Veeva, and myCIMS.
If you are having difficulty in applying or if you have any questions, please contact Ria Tailor at r.tailor@proclinical.com.
Apply Now:
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.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
