Senior Validator
New
S
SiiIdentity and access management
From anywhere in Poland or UkraineFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Advanced level of English; intermediate level of Spanish (nice to have)
- Experience
- Minimum 5 years of experience in validation within regulated environments, specifically GxP processes
- Required Skills
- Change Management
Requirements
- Have a minimum of 5 years of validation experience in regulated environments, specifically GxP processes.
- Have deep expertise in GxP, GAMP 5, and EU GMP Annex 11 regulations.
- Understand FDA 21 CFR Part 11 and its implications for system validation.
- Have practical experience creating and maintaining validation documentation, including requirements, risk assessments, and validation reports.
- Be able to collaborate effectively with cross-functional teams, including Quality, IT, and Security.
- Have an advanced level of English.
- Cloud-based IAM solutions experience is a nice-to-have.
- Familiarity with automated validation tools is a nice-to-have.
- An intermediate level of Spanish is a nice-to-have.
Responsibilities
- Define and maintain the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform supporting GxP processes.
- Plan, prepare, review, and approve traceable validation documentation, ensuring adequate evidence is available before release and during operation.
- Define risk-based testing approaches and review evidence for identity and account management, roles and access rights, and security controls.
- Assess changes, software releases, and configuration changes for GxP impact, and define required validation and regression testing.
- Manage validation-related deviations and CAPAs, including investigation support and verification of evidence before closure.
- Maintain the platform's validated state through change management, periodic reviews, and supplier oversight.
- Clarify responsibilities and data ownership across IAM and connected applications.
- Work with Quality, System, and Process Owners, and service providers to resolve risks and deliver compliant solutions.
- Represent IAM validation in audits and inspections, and lead improvements to simplify or automate assurance activities.
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