Quality Manager (CSV) (Barcelona)

Quality Manager (CSV) (Barcelona)

07 nov
|
B. Braun Medical
|
Barcelona

07 nov

B. Braun Medical

Barcelona

Remoto: Trabajo híbrido

Experteer OverviewIn this role you advance computerized system validation (CSV) to ensure compliant, high-quality healthcare software and services. You will work within the Group Digital Department to implement GAMP 5 aligned processes, support risk-based qualification, and create robust documentation. You'll partner with cross-functional teams on cloud-based and on-premise systems, driving quality through training and governance. This position offers a meaningful impact on patient care by shaping validation practices in a fast-paced, collaborative environment.Compensaciones / BeneficiosDevelop, maintain, and improve CSV processes, templates, and guidance per GAMP 5 and internal requirementsPlan and execute risk-based qualification and validation for computerized systems, incl. cloud services and web appsCreate and review qualification and validation docs (plans, risk assessments, requirements, test docs, traceability matrices, reports)Ensure CSV requirements are integrated into system development,



implementation, operation, and change managementDevelop and deliver training on qualification and validationAct as subject matter expert within GDDResponsabilidadesDegree in Computer Science, Engineering, Information Technology, Quality Management, or comparable fieldProven experience in CSV, qualification, software QA, or related quality disciplineGood knowledge of GAMP 5 principles and risk-based qualification approachesExperience with cloud-based services, computerized systems, and software development processesAbility to create and review qualification and validation documentation and quality proceduresStrong written and verbal communication in EnglishRequisitos principalesHybrid working model23 calendar days of annual leave10% variable bonusPrivate health insuranceMeal allowanceCompany-funded training and certifications

📌 Quality Manager (CSV) (Barcelona)
🏢 B. Braun Medical
📍 Barcelona

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