Senior IT Validation Lead - Pharma CSV Expert

Roche; Madrid; Presencial; EUR 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Attractive benefits

Business travel opportunities

Descripción de la vacante

Roche is seeking a Senior IT Validation Professional to ensure quality of computerized systems across diverse product lines. You will design, develop, and approve qualification deliverables, validation plans, and reports, aligning with GxP and CSV standards.

Expect to lead validation efforts, maintain audit readiness, and collaborate with cross-functional teams across international sites while driving continuous improvement in CSV practices. English proficiency required.

Formación

• 6+ years of IT/software validation experience in pharma, including CSV/CSA and GAMP.
• Lead validation/qualification for projects and system maintenance.
• Author qualification deliverables, validation plans, reports, and registries.
• Review validation and testing deliverables and system documentation.
• Maintain systems in audit/inspection readiness for global agencies.
• Regulatory knowledge of CSV (FDA CFR 21 Part 11, Annex 11, EU GMP Annex 1).
• Proficient with EDMS (Veeva) and ALM tools (ServiceNow/JIRA).
• Strong communication to non-experts and cross-functional teams.

Responsabilidades

• Validation/Qualification Strategy: determine approaches and deliverables for GxP systems.
• Documentation Review: develop/approve validation plans and reports; review test plans and reports.
• Testing and Consultancy: verify tests and advise on deviations per procedures.
• Deviation and Root Cause Analysis: support investigations and corrective actions.
• Audit/Inspection Preparation: act as CSV expert for audits and inspections.
• System Maintenance: keep validated state and audit readiness.
• Periodic Reviews: lead or support periodic system reviews.
• Continuous Improvement: implement frameworks, propose tools, optimize processes.
• Training and Knowledge Sharing: train teams on validation/quality topics.

Conocimientos

CSV/CSA knowledge

Agile/SAFe

Risk assessment

Cross-functional collaboration

English communication

Educación

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Herramientas

EDMS (Veeva)

ALM Tools (ServiceNow/JIRA)

Descripción del empleo

Roche is seeking a Senior IT Validation Professional to ensure quality of computerized systems across diverse product lines. You will design, develop, and approve qualification deliverables, validation plans, and reports, aligning with GxP and CSV standards.

Expect to lead validation efforts, maintain audit readiness, and collaborate with cross-functional teams across international sites while driving continuous improvement in CSV practices. English proficiency required.