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Full-Time CSV Consultant
Job Description
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors, with more than 800 employees and 20 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means to join a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.
We are looking for a VALIDATION CONSULTANT to support our projects and growing business in Hungary.
RESPONSIBILITIES include, but are not limited to:
- Resolution of fundamental Computer System Validation compliance issues on assigned projects
- Writing, reviewing and executing of 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 document repository (Document Navigator) and approved following the prescribed SOP
REQUIREMENTS:
- 1-2 years of experience in Computer System Validation
- Hungarian and English: full proficiency
- 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
- Excellent communication skills
LOCATION: Budapest (Hungary)
How to Apply
Please, send your application to recruiting@pqegroup.com915 total views, 0 today