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 our continuous growth, we are currently seeking a skilled CSV / ERP Specialist with fluency in French and a good understanding of English for document drafting. The ideal candidate will have expertise in ERP systems, Computer System Validation (CSV), and general IT operations, ensuring compliance with industry standards and regulatory requirements.
Location: Charleroi, Belgium.
Key Responsibilities
* ERP System Management: Configure, maintain, and optimize ERP systems to meet business needs
* Computer System Validation (CSV): Develop and execute validation protocols (IQ/OQ/PQ) for GxP-regulated systems
* Technical documentation: Prepare technical documentation (SOPs, validation reports, risk assessments) in French, with the ability to understand and review English documentation
* Compliance: Ensure adherence to regulatory standards (FDA, GAMP, EU Annex 11, etc.)
* IT Support: Assist in troubleshooting and maintaining IT infrastructure related to ERP and validated systems
* Collaboration: Work with cross-functional teams (QA, IT, Operations) to ensure system integrity and compliance
Qualifications
* Education: Bachelor’s degree in Computer Science, IT, Engineering, or a related field
* Experience: Proven experience with ERP systems (SAP, Oracle, Microsoft Dynamics, etc.)
* Strong background in CSV / GxP environments (pharmaceutical, medical devices, or life sciences is strongly preferred)
* Languages: Fluency in French (written and spoken, for documentation and communication) and good understanding of English (for reading and drafting technical content)
* Skills: Knowledge of regulatory requirements (FDA 21 CFR Part 11, EU GMP); familiarity with IT infrastructure and systems integration; analytical mindset with strong problem-solving abilities
Preferred Qualifications
* Certification in CSV, ITIL, or ERP systems
* Experience in project management or IT auditing
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 feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.