Senior IT Validation Lead – CSV for Pharma

F. Hoffmann-La Roche AG; Madrid; Presencial; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits package

Business travel opportunities

International collaboration

Descripción de la vacante

Roche is seeking a Senior IT Validation Professional to drive qualification across GxP computerized systems. You will design validation strategies, develop and approve validation plans, and ensure inspection readiness.

Your role includes auditing/test record reviews, risk assessments, and collaborating with diverse teams to maintain compliant, validated environments. Ideal candidates bring 6+ years in IT/software validation within pharma, strong knowledge of CSV/CSA and GAMP, and experience with

Formación

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• 6+ years of IT & Software Validation (CSV/CSA, GAMP) in pharma environment.
• Experience authoring qualification deliverables, validation plans, reports, and registries.
• Familiarity with CSV regulations (FDA Part 11, Annex 11, EU GMP Annex 1).

Responsabilidades

• Define validation approaches and identify required deliverables for GxP computerized systems.
• Develop, approve validation/qualification plans and reports; review test plans and records.
• Provide testing consultancy on deviations and corrective actions.
• Lead investigations into deviations and root cause analyses.
• Prepare and support audits/inspections as CSV expert.
• Maintain validated state of systems and support periodic reviews.
• Propose process improvements and share validation knowledge.
• Collaborate with cross-functional teams in agile environments.

Conocimientos

Validation strategy

Documentation

Testing consultancy

Root cause analysis

Audit readiness

Cross-functional collaboration

English communication

Leadership

Educación

Bachelor’s degree in Computer Science, Engineering, Life Sciences

Herramientas

EDMS (Veeva)

ALM Tools (ServiceNow, JIRA)

Descripción del empleo

Roche is seeking a Senior IT Validation Professional to drive qualification across GxP computerized systems. You will design validation strategies, develop and approve validation plans, and ensure inspection readiness.

Your role includes auditing/test record reviews, risk assessments, and collaborating with diverse teams to maintain compliant, validated environments. Ideal candidates bring 6+ years in IT/software validation within pharma, strong knowledge of CSV/CSA and GAMP, and experience with