Specialist QA - QMS
To join a dynamic Global QA team in vaud canton, we're looking for a Specialist QA - QMS candidate to support the QA oversight for EU functions and country affiliates worldwide.
Based in Lausanne
RESPONSIBILITIES
- Provide operational QA support for the implementation and maintenance of GxP QMS for country affiliates.
- Support QA operations for EU GxP functions in QMS development.
- Assist in improving the GxP QMS within the QA team.
- Deliver operational QA support for the implementation, improvement, and maintenance of Country Affiliate QMS, including SOP review, eDMS implementation, and procedural document updates.
- Participate in developing Quality Metrics/Dashboard for GxP areas, including timely management of training reports and dashboards, and handling training matrices for country affiliates.
- Provide operational QA support for various EU GxP functions (Medical Affairs, Public Affairs, Clinical teams, etc.) in QMS development as needed.
- Assist in implementing and maintaining the Quality Management System, including support for change control and deviations, ensuring continuous process improvement.
PROFILE
- A Bachelor's degree in a science or healthcare-related field.
- 1 to 3 years of experience in a pharmaceutical or biopharmaceutical company in a QA or QMS role, focusing on training management, SOP implementation, deviation management, and change control.
- Experience with Veeva eDMS, eLMS, and eQMS
- Experience as local QA for a country affiliate/subsidiary or in Clinical, Pharmacovigilance, or Medical Affairs is a plus.
- Fluency in written and spoken English (company language); knowledge of another language like French is an asset.