Description
Takeda is hiring a Computer Systems Validation Specialist to develop and oversee validation documentation, lead validation planning and execution, perform IT platform and infrastructure qualification, support application and infrastructure operations, resolve deviations, and provide guidance on GAMP 5, FDA and EU GxP, and ISO requirements. The role requires at least three years of similar experience, a relevant bachelor's degree, computer system validation and infrastructure qualification experience, knowledge of GAMP 5 and 21 CFR Part 11, and familiarity with agile quality tools. It is based in Mexico City – Santa Fe on a hybrid schedule with at least ten in-office days per month.
