CSV Project Manager

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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 a constant growth, we are looking for a CSV Project Manager to join our team in Barcelona or Madrid, Spain.

This is a hybrid role ( 2 days working from home ) and requires strong Spanish language skills at a professional level.

Overview

Responsibilities

• Management of Computer System Validation (CSV) projects : Leading and executing CSV projects, ensuring compliance with GxP regulations, 21 CFR Part 11, and other relevant regulations
• Development of CSV strategies and protocols : Creating and implementing strategies, plans, and validation protocols (IQ / OQ / PQ) for laboratory, manufacturing, and enterprise application computer systems.
• Risk assessment and mitigation : Conducting risk assessments and developing mitigation strategies for computer systems.
• Conducting validation activities : Reviewing documentation, performing tests, and managing deviations during validation activities.
• Regulatory consulting in the CSV field : Providing expert advice on regulatory requirements and industry best practices for computer system validation.
• Cross-functional collaboration : Working closely with IT, Quality Assurance, and Regulatory Affairs teams to ensure the success of projects.
• Training and mentoring : Training and supporting junior consultants and client personnel on CSV principles and practices.

Requirements

Location

Barcelona / Madrid, Spain

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there\'s a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

About PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.

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