Remote Validation Lead — Holistic Data Management

Ambit Iberia

Sant Cugat del Vallès

Remoto

EUR 70.000 - 90.000

Tempo pieno

7 giorni fa

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Vantaggi offerti da questo lavoro

Medical insurance

Public transport ticket

Childcare support

Gym discounts

Training catalogue

Referral program

Descrizione del lavoro

Ambit Iberia is seeking a Validation Manager to lead validation activities for a Holistic Data Management initiative within a global pharmaceutical environment. You will ensure that systems meet CSV, GxP, GLP standards across their lifecycle.

The role collaborates with Business stakeholders, IT System Leads, QA, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities, including audits and inspections.

Competenze

Strong knowledge of CSV principles and methodologies.
Familiarity with FDA 21 CFR Part 11, EU GMP Annex 11, GxP requirements.
Experience in preparing validation documentation in regulated environments.
Understanding of validated IT systems, software, infrastructure, and integrations.
Excellent analytical, documentation, and stakeholder management skills.

Mansioni

Own and coordinate all validation activities for the system.
Prepare, review, and maintain Validation Plans, Test Documentation, Traceability Matrices, and Validation Summary Reports.
Lead qualification activities across QA and Production environments.
Coordinate validation testing activities, deviation management, and defect resolution.
Ensure compliance with CSV, GxP, GLP, and applicable validation standards.
Review and support SOPs, training materials, and go-live documentation.
Collaborate with Business stakeholders, IT System Leads, Quality Assurance, and System Owners to support approvals.
Act as a key compliance partner during audits and inspections.