Our client is a global Pharma company helping millions of customers worldwide with healthcare.

They require a Business Analyst for the creation or update of validation documents as part of the validation of computer systems:


Role

*Validation Planning
*Creation and processing of change controls
*User Requirements and risk Assessment
*21 CFR Part 11 Compliance Assessment
*Configuration Specification
*Requirement Test Cases
*Traceability Matrix and signature Resource Log
*Functional / Requirements Testing Plan and reporting
*Review of project-related IT documents to prepare the final review and approval
*Participation in weekly specification meetings for the detailed specification of necessary requirements between users and supplying partners



Experience

*You'll be an experience business analyst with 7 years+ experience within the Pharma industry
*Validation of documents and compliance within the Pharma industry is essential
*Solid Experience with 21 CFR Part 11 regulations
*Fluent German and English is essential for this role

This is mainly work from home with some very occasional trips to the client site in Germany