Csv Consultant

hace 2 semanas


CentroMadrid, España PQE Group A tiempo completo

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 1200 employees, 45+ nationalities and 27 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for a Computer System Validation Consultant to implement our new team in Madrid, Spain.

Responsibilities include, but are not limited to:

- Resolution of fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing and executing computer validation documentation
- Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
- Preparation of project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
- Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP

**Requirements**:

- +1 year of experience in a similar role
- Spanish native, English full proficiency (any additional language will be considered a plus)
- Availability to travel domestically and internationally up to 60%
- Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11,)
- Ability to work as a team player in a consulting environment

Location: Madrid, Spain

Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Tipo de puesto: Jornada completa

Beneficios:

- Programa de formación
- Ticket restaurante

Horario:

- Turno de 8 horas

Posibilidad de trasladarse/mudarse:

- Centro-Madrid, Madrid: Desplazarse al trabajo sin problemas o planificar mudarse antes de comenzar a trabajar (Obligatorio)

Experiência:

- CSV: 1 año (Obligatorio)

Idioma:

- Inglés (Obligatorio)


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