description du poste

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 across Europe, Asia, and the Americas.

Due to our constant growth, we are looking for a Medior Computer System Validation (CSV) Consultant to support our projects in Fleurus. This is a full-time position focused on the validation and documentation of regulated computerized systems within a GMP environment.

You will be responsible for:

• Performing Computer System Validation (CSV) activities for electronic batch record (EBR) systems.
• Drafting and reviewing User Requirement Specifications (URS) and associated validation deliverables in alignment with GAMP5 and regulatory expectations.
• Ensuring compliance with regulatory guidelines in the documentation of validation activities.
• Collaborating with cross-functional teams including IT, Quality Assurance (QA), and Operations to ensure validation processes meet all regulatory requirements.
• Supporting the creation of validation protocols, reports, and other key documentation.
• Ensuring the proper implementation of quality systems and maintaining high standards in all documentation processes.

About you:

• Strong experience in Computer System Validation (CSV) in regulated environments, particularly with Electronic Batch Record (EBR) systems.
• Proficient in drafting and reviewing User Requirement Specifications (URS) and validation documentation.
• Knowledge of GAMP5 guidelines and regulatory expectations for GMP environments.
• Excellent documentation skills with attention to detail.
• Fluency in both French and English, with the ability to communicate effectively with cross-functional teams.
• Ability to work independently and as part of a team.
• Previous experience working in a pharmaceutical or medical device industry is preferred.

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 from the Hiring Manager interview, the 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 toward an amazing future with us.