e are a service provider company, leader in the Pharmaceutical and Medical Device sectors, with more than 900 employees and 25 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 CSV Consultant to implement our new team in Barcelona (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
- 2 years of experience in a similar role
- 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
- Excellent communication skills
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.