Requirements: English
Company: PQE Group
Region: Huningue , Grand Est
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 looking for a Cleaning Validation Consultant to support activities related to process validation and cleaning validation within a GMP-regulated pharmaceutical manufacturing environment. The consultant will be responsible for drafting and executing validation protocols, performing risk assessments, and managing related documentation in compliance with regulatory standards. Draft and execute Process Validation Protocols (IQ/OQ/PQ) in compliance with current GMP and internal validation master plans. Develop and implement Cleaning Validation protocols, ensuring compliance with product carryover limits and cleaning procedures. Write and review validation reports, SOPs, and supporting documentation in accordance with regulatory and internal quality standards. Coordinate validation activities with production, quality assurance, engineering, and other relevant departments. Support ongoing lifecycle validation by identifying gaps and contributing to continuous improvement initiatives. Masters degree in Pharmaceutical Sciences, Chemistry, or a related scientific discipline (5 years of higher education). At least 1 year of experience (including internships or apprenticeships) in validation or QA qualification in a pharmaceutical GMP environment. Solid understanding of EU GMP requirements, including Annex 15 (Qualification and Validation). Strong knowledge of process validation principles, cleaning validation strategies, and documentation best practices. Proficient in Microsoft Office (Word, Excel, PowerPoint). Knowledge of galenic forms (oral solids, liquids, injectables, etc.) Fluent in English (spoken and written); French is a plus depending on the site environment. 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. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.