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Senior Validator (f/m/x)

seniorremoteWarszawa, PLScore 68/1003d ago
Stack
GXPGamp 5EU GMP Annex 11FDA 21 CFR Part 11System Validationcloud
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Description
We are looking for a Senior Validator to join our team and lead lifecycle validation for a global Identity and Access Management (IAM) platform. In this role, you will ensure that functions supporting regulated GxP processes remain compliant, controlled, and ready for audits. You will collaborate with various teams, including Quality, IT, and Security, to translate regulatory requirements into effective controls and apply a consistent validation approach as the platform evolves. This position offers the flexibility of remote work, allowing you to contribute to an important project from anywhere in Poland or Ukraine. If you are passionate about maintaining compliance in a dynamic environment, this opportunity may be the right fit for you. Your tasks Defining and maintaining the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform supporting GxP processes Planning, preparing, reviewing, and approving complete and traceable validation documentation, ensuring adequate evidence is available before release and during operation Defining a testing approach based on risk and reviewing evidence for key IAM processes such as identity and account management, roles and access rights, and security controls Assessing changes, software releases, and configuration changes for GxP impact, and defining the required validation and regression testing Managing validation-related deviations and CAPAs in accordance with applicable procedures, inclu
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