Computer System Validation

hace 2 semanas

Barcelona, 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 1500 employees, 45+ nationalities and 28 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 IT Compliance (CSV) Senior Consultant to implement our new team in Barcelona, Spain.

Responsibilities include, but are not limited to:

- Support in the Validation Life Cycle of Computerized Systems with special attention to the SAP system, laboratory systems (LDA's) and production control systems: Drafting of Validation Plans; Drafting and Review of Specification documentation.
- Specification of User Requirements.
- Risk Analysis.
- Drafting of DQ, IQ, OQ and PQ testing protocols.
- Execution of validation tests and the phase reports.
- Provider support during systems implementation.
- Drafting and Review of Standard Operating Procedures (SOP).
- Acting of IT/QA Compliance: Evaluation of the State of compliance of the Computerized Systems with respect to the requirements of Data Integrity. Proposal for remedial actions based on the level of risk associated with the GAPs found.
- Support and execution of Data Integrity Compliance remediation actions on Laboratory and Production Systems.
- Review of generated validation documentation.
- Preparation/updating of Policies, SOPs, Standards and Validation Templates regarding standards and Corporate Policies.
- Review of Validation documentation regarding compliance with SOPs and approved validation standards.

**Requirements**:

- +3 years 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: Barcelona, 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, Contrato indefinido

Beneficios:

- Programa de formación
- Ticket restaurante

Horario:

- Turno de 8 horas

Posibilidad de trasladarse/mudarse:

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

Experiência:

- CSV: 3 años (Obligatorio)

Idioma:

- Inglés (Obligatorio)

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