CSV Specialist: Validate & Modernize GxP Systems (Hybrid)

Oxford Global Resources; Barcelona; Híbrido; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Competitive compensation

Descripción de la vacante

Oxford Global Resources in Barcelona is seeking a Computerized Systems Validation (CSV) Specialist to ensure GxP computerized systems stay compliant, reliable, and inspection-ready throughout their lifecycle.

You will lead validation projects, apply risk-based methods per GAMP 5, develop IQ/OQ/PQ docs, support upgrades, audits, and cross-functional collaboration in a fast-paced pharmaceutical environment. This role offers international exposure and a focus on continuous learning.

Formación

• Experience in Computerized System Validation within pharmaceutical/regulated environments.
• Knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.

Responsabilidades

• Lead validation projects for computerized systems from implementation through retirement.
• Define validation strategies using risk-based approaches.
• Develop and review validation documentation (URS, IQ/OQ/PQ, Traceability Matrices, Validation Reports).
• Support system upgrades, infrastructure changes, and periodic reviews.
• Ensure GMP compliance and participate in audits/inspections as CSV SME.
• Manage deviations, CAPAs, and change controls.
• Collaborate with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams.
• Drive continuous improvement and digital transformation initiatives.

Conocimientos

GxP validation

Risk-based validation

Stakeholder management

Cross-functional collaboration

Descripción del empleo

Oxford Global Resources in Barcelona is seeking a Computerized Systems Validation (CSV) Specialist to ensure GxP computerized systems stay compliant, reliable, and inspection-ready throughout their lifecycle.

You will lead validation projects, apply risk-based methods per GAMP 5, develop IQ/OQ/PQ docs, support upgrades, audits, and cross-functional collaboration in a fast-paced pharmaceutical environment. This role offers international exposure and a focus on continuous learning.