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.

In this full-time role, the CSV Senior Consultant will participate in Computer System Validation projects for clients in the Pharmaceutical and Medical Devices Industries. The Senior Consultant will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project.

You will be responsible for

• Resolution of fundamental Computer System Validation compliance issues on assigned projects
• Writing, reviewing and executing computer validation documentation
• Primarily accountable for the validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report)
• 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
• Implementation experience in Management Systems

Requirements:

• 6+ years' experience in Computer Systems Validation
• Excellent knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11 and relevant predicate guidances
• Strong experience with SAP/ERP Validation
• Experience as Key User in ERPs (nice to have)
• Native in Spanish; fluent in English (at least B2)
• Experience with Pharmaceutical Industry

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.

Working at 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.