job location Job Location:

Remote - Japan

 

CSV Consultant

Requested Languages:

English  Japanese
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job at pqe

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 many Computer System Validation Consultants to join our CSV Team in Japan.
Working in a consulting reality as PQE Group will give you the chance to work on projects for the most important national and international pharmaceutical companies. This opportunity will allow you to travel within Japan to visit our clients’ sites and quickly increase your professional experience thanks to the constant support of a multicultural team of expert consultants and continuous on the job training.



    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
  • 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 life cycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP
    Requirements:
  • +2/3 years of experience in CSV
  • English: fluent (any additional language will be considered a plus)
  • Availability to travel domestically up to 30% of the time

If interested, please send your resume clicking the "APPLY NOW" button on this page.

Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order 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.


job at pqe