- Posted 28 November 2019
- Salary€58 - €60 per hour
- LocationBrussels, Belgium
- Job type Contract
- Contact NameSheridan Williams
As the validation Analyst you will help to improve my client's DI Automation and Production systems across the EMEA region.
The goal is to improve patient safety and information quality and compliance thus reducing the risk of inspection and audit observations by being compliant with the last FDA, EUDRALEX and other regulatory agencies.
Key skills and experience
*Detailed experience as a Validation Analyst
*CSI assesses compliance in access security, data integrity, traceability, validation and periodic reviews.
*Assessing systems in production and labs against data integrity requirements to identify and evaluate the magnitude of GAPs (High, Medium, Low)
* Fixing documentary GAPs (e.g. missing SOP)
*Fixing technical GAPs (e.g. User segregation of duties, folder protection, software upgrade)
*Drafting validation packages (URS, FDS, IQ, OQ, PQ)
*Executing validation tests
*Willingness to Travel : 20 to 50%