Our client, a dynamic bio-pharmaceutical company headquartered in Switzerland and covering multiple therapeutic areas, is looking for a Quality Management Training Specialist for a 6 months contract role based in the French Speaking area of Switzerland.
The ideal candidate should have a previous experience in Quality Management Systems Training - particularly with Clinical Systems or documentation. Do not hesitate in applying in case you are a CRA or Clinical Monitor looking to continue your career within a Headquartered role.
As a Quality Management Training Specialist, you will support the development, implementation and completion of GxP training program, e-learning sessions and SOPs self-training for the R&D organization.
- To support the development, implementation of GxP training program, training modules, training matrices for the R&D organization;
- To support the process of handling and tracking internal training related to GxP for the clinical studies;
- To link SOPs with ENNOV training module and create where necessary new training modules;
- To coordinate and ensure completion of the GxP training sessions, e-learning sessions and SOPs self-training;
- To support and perform validation activities of electronic training and documentation system;
- To support administrative processes for the Quality Management department (budget follow-up, processing of travel expenses, invoice, contracts, support document collection for audits,etc.);
- To follow-up CAPA activities and to issue CAPA metrics to ensure GCP and GMP inspection readiness;
- To support the KPIs processes for the Quality Management department.
Qualifications and Experience:
- Documentation or Training administrative experience;
- Clinical documentation or systems training administrative experience;
- Good practical experience in handling electronic documentation systems under GCP;
- Good practical experience in handling electronic documentation systems;
- Excellent knowledge in using Microsoft Office (Word, Excel, PowerPoint, SharePoint…);
- Good practical experience in creating and maintaining excel databases and macros;
- Rigor, excellent coordination capabilities and attention to detail;
- Flexibility and adaptability, ability to multi-task;
- Capacity to keep an overall view while bringing enough attention to details;
- Fluency in English and French;
- Relevant working/residency permit or Swiss/EU-Citizenship required.