Computarized Validation System Consultant en PHARMA QUALITY EUROPE

Computarized Validation System Consultant
PHARMA QUALITY EUROPE | (5) ofertas activas
Pharma Quality Europe (PQE), Empresa Internacional que ofrece servicios de asesoría, consultoría y soluciones integrales de calidad para empresas reguladas del ámbito del LifeScience y particular en el contexto sanitario (Farmacéutico, Químico Farmacéutico, Dispositivos Médicos, Hospitalario y afines).

La Compañía presenta actualmente más de 500 consultores, distribuidos a nivel mundial en sus diferentes sedes operativas/representaciones: Italia, España, Suiza, Alemania, Israel, Rusia, China, Japón, India, USA, México, Brasil y Ecuador.
Ciudad de México, 23 Jun.
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Descripción
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 being a part of 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,
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Responsibilities include, but are not limited, to the followings:



Resolution of fundamental Computer System Validation compliance issues on assigned projects
Writing, reviewing and executing computer validation documentation
Primarily accountable for the validation of compurterized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report)
Very good knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11 and relevant predicate guidances
Capable to assess electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach and suggest the most appropriate mitigation/remediation actions.
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 documents

Numero de vacantes: 1

Ventajas sociales o económicas
SALARY + BENEFITS
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Requisitos
At leat 2- 5 years experience in Pharmaceutical environment, with focus on CSV
English: fluent (any additional language will be considered a plus)
Availability to travel

Estudios mínimos
Licenciado
Experiencia mínima
2 años
Disponibilidad para viajar
El 60% del tiempo laboral



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