Csv Senior Consultant- Cali y Bogotá

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 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

Número de vacantes: 2

Modalidad de trabajo: Híbrido (25%)

**Ventajas sociales o económicas**

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Computer System Validation Senior Consultant to support our projects in Cali and Bogotá, Colombia

"

**Requisitos**

About you:
At least 5 years of experience in CSV in pharmaceutical industry

Bachelor´s Degree in Science or Engineering (Computer Sciences, Engineering, Chemistry, Biotechnology, etc )

Integrity, strong ethics, analytical skills and attention to details

Native in Spanish; fluent in English (at least B2)

Full availability to travel

Estudios mínimos
Licenciado

**Idiomas**:
Inglés nível Alto.
- Experiência mínima
5 años

Disponibilidad para viajar
El 60% del tiempo laboral