MSI Pharma are working with one of the top pharma companies in the world to hire a Quality Engineer for a 12 month contract in Switzerland.


Scope of Work to include the following:

Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements. This includes supporting project deliverable; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
Assess supplier drawings and process information to support project deliverable:
o Manufacturing Process Information and Controls
o Production risk management file
o Validation protocols and reports
o Direct part marking documentation
Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
Cross coordinate Workstream activities/interdependencies with other workstream and project teams.
Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;
Support definition and clarification of EU MDR supplier related process requirements.
Support Review and Approval EU MDR Change Projects as applicable.
Support Supplier Quality Functional Impact Assessments as applicable.
Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
Support the update of supplier related Inspection Criteria as applicable.