Senior CSA Validation Lead for Computerized Systems

Fresenius Kabi; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading healthcare company in Barcelona is looking for a Validation Manager to support computerized systems in compliance with industry regulations. You'll guide validation projects, audit vendors, and train teams to uphold quality management principles. The ideal candidate has a Master's degree and profound experience in computerized system validation, familiarity with EU GMP and US FDA regulations, as well as strong leadership and problem-solving skills. Collaborative environment focused on delivering impactful therapies.

Formación

• Master's degree or comparable is required.
• Significant experience in computerized system validation and software assurance is necessary.
• Knowledge of EU GMP regulations and GAMP 5 is essential.

Responsabilidades

• Lead validation projects and support development teams in compliance for computerized systems.
• Audit software vendors and maintain their qualified status.
• Train teams in validation principles and actively improve processes.

Conocimientos

Computerized system validation

EU GMP Annex 11

US FDA 21 part 11

GAMP 5

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Polarion

Office

Quality Management principles

Problem-solving

Leadership

Presentation skills

English language

Educación

Master's degree or comparable

Herramientas

Polarion

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Descripción del empleo

A leading healthcare company in Barcelona is looking for a Validation Manager to support computerized systems in compliance with industry regulations. You'll guide validation projects, audit vendors, and train teams to uphold quality management principles. The ideal candidate has a Master's degree and profound experience in computerized system validation, familiarity with EU GMP and US FDA regulations, as well as strong leadership and problem-solving skills. Collaborative environment focused on delivering impactful therapies.