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.
Overview
We are seeking a CSV Analyst SAP to join a dynamic team working on a large-scale SAP S/4 HANA transformation project. This role is focused on validation and compliance within the SAP landscape, ensuring all processes align with regulatory requirements and internal quality standards. The successful candidate will work closely with cross-functional teams, including compliance leads, foundation experts, and external vendors, to support the validation strategy throughout the project lifecycle.
Responsibilities:
* Ensure full compliance with regulatory requirements and internal Computer System Validation (CSV) standards within the SAP S/4 HANA implementation project.
* Collaborate closely with internal teams and external vendors to coordinate validation activities and timelines.
* Analyze and translate business and compliance requirements into validation deliverabl
* es.Author and review validation documentation, including URS, FS, RTM, test plans, test scripts, and final reports.
* Support internal and external audits by providing accurate and complete validation documentation.
* Participate actively in project meetings, providing regular updates on validation progress and raising risks or issues when needed.
* Assist in the identification and resolution of validation-related deviations, including root cause analysis and CAPA implementation.
* Foster strong cross-functional collaboration to ensure a quality- and compliance-driven project environment.
Qualifications:
* Minimum 3 years of hands-on experience in SAP validation within regulated environments.
* Solid understanding of CSV principles, including GxP, FDA/EMA regulations, and GAMP 5 guidelines.
* Proven ability to create, manage, and review validation documentation across the lifecyle.
* Strong working knowledge of SAP ECC and/or SAP S/4 HANA, with a focus on validation and compliance.
* Excellent organizational skills and the ability to manage multiple priorities independently.
* Fluent in English, both written and spoken, with clear communication skills.
Preferred Qualifications:
* Familiarity with pharmaceutical manufacturing processes and SAP Quality Management (QM) modules.
* Experience navigating complex stakeholder environments in matrix organizations.
* Knowledge of French and/or Dutch is a plus.
Next Step
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.