Description
My client a global organisation is seeking a Validation Analyst (Automated Systems) to join their team.
As the Validation Analyst you will be responsible for global critical programs initiated to assist plants to identify and remediate any compliance
The goal is to improve patient safety and information quality and compliance, the program also seeks a long-term improvement in understanding and using good Data Integrity practices.
*Detailed experience with IT validation related and automated systems
*Reliability, organisational skills and ability to work under pressure are key.
*English Fluent
*Inventorying systems
* Assessing systems in production and labs against data integrity requirements to identify and evaluate the magnitude of GAPs (High, Medium, Low)
* Fixing documentary GAPs (eg missing SOP)
*Fixing technical GAPs (eg User segregation of duties, folder protection, software upgrade)
*Drafting validation packages (URS, FDS, IQ, OQ, PQ)
*Executing validation testing.
*Travel