Validation Analyst

Posted 28 November 2019
Salary€58 - €60 per hour
LocationBrussels, Belgium
Job type Contract
Contact NameSheridan Williams

Job description

My client a global pharmaceutical company is seeking Validation Analyst to join their team.

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%