Тип вакансії: Повна зайнятість

Розташування:

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 and ready for audits or inspections. You will collaborate with Quality, IT, Security, and business teams to translate regulatory requirements into effective controls. This position is fully remote, allowing you to work from anywhere in Poland or Ukraine. If you are passionate about ensuring compliance in digital identity management, 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, including requirements, risk assessments, traceability records, test documentation, deviations, and validation reports
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 incidents for GxP impact, and defining the required validation and regression testing
Managing validation-related deviations and CAPAs, including investigation support and verification of adequate evidence before closure
Keeping the platform in a validated state through effective change and incident management and periodic reviews
Clarifying responsibilities and data ownership across IAM and connected applications
Representing IAM validation in audits, regulatory inspections, and management reviews, clearly explaining the validation scope and controls
Identifying compliance gaps and leading improvements to simplify or automate assurance activities

Requirements:
Minimum 5 years of experience in system validation within regulated environments
Deep expertise in GxP, GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11
Strong command of validation documentation practices and lifecycle controls
Proven experience in assessing GxP impact of changes and managing validation-related deviations
Advanced level of English
Tax residence in Ukraine required

Nice to have
Experience with IAM platforms and related technologies
Familiarity with cloud-based solutions and their validation requirements
Intermediate level of Spanish

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