Beschreibung
QA Manager Systems Expert GxPFulltime
Start date ASAP
12 Month Contract
Responsibilities
The QA manager, GxP systems is responsible for the implementation and daily oversight of QA GxP Quality Systems.
- Facilitate the GxP document/QA process management system
- Manage the incoming requests for QS Documents framework modification, and make decision on integration
- Oversee the GxP compliance decision of the QS Document life cycle
- Manage the training assignment discussion and implementation with line managers
- Coordinate the Veeva expert network
- own and maintain some of the QS Documents, including user manuals, describing QA owned GxP systems processes and activities, and related documentations
Requirements
- Very good knowledge of GxP regulated environments and requirements
- Good understanding of ICH Q10 and quality systems in GxP environment
- Ability to prepare documents and communications in a clear and concise style, impactful for business stakeholders as well as technical ones
- Experienced in giving presentations and standing in front of an audience
- Experienced in and capable of dealing with people of different cultures, educational backgrounds, and computer knowledge
- Experience in putting oneself in the position of a GxP system user, and based on this, to shape training, answer users' inquiries accordingly and emphasize the benefits of GxP systems
- Fluent in English (written and spoken), French and/or German is a plus