12 oct
|
Ambit Iberia
|
Barcelona
12 oct
Ambit Iberia
Barcelona
We are looking for an IAM Validation Manager to ensure the validated state, compliance, and quality of an Identity & Access Management platform supporting GxP processes within a regulated pharmaceutical environment.
La información a continuación detalla los requisitos del puesto, la experiencia esperada del candidato y las cualificaciones correspondientes.
Tasks & Responsibilities
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- Define and maintain the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform.
- Prepare, review, and approve validation documentation, including requirements, risk assessments, traceability, test protocols, deviations, and validation reports.
- Define risk-based testing approaches covering identity and account management, roles and access rights, access requests and reviews, interfaces, audit trails, reporting, and security controls.
- Assess changes, releases, cloud updates, incidents, configuration changes, and integrations for GxP impact and determine validation and regression testing requirements.
- Manage validation deviations and CAPAs,
supporting investigations, corrective actions, follow-up, and closure.
- Maintain the platform in a validated state through change and incident management, periodic reviews, supplier oversight, backup and recovery, archiving, and system retirement.
- Clarify responsibilities and data ownership across IAM platforms, source systems, workflows, connected applications, and service providers.
- Collaborate with Quality, System and Process Owners, technical teams, business experts, and suppliers to address risks and implement sustainable solutions.
- Represent IAM Validation during audits, self-inspections, regulatory inspections, and management reviews.
- Identify compliance gaps and opportunities to simplify or automate validation and assurance activities.
Skills
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- Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field, or equivalent professional exper
📌 IAM Validation Specialist | Pharma (Barcelona)
🏢 Ambit Iberia
📍 Barcelona