Requirements: English
Company: PQE Group
Region: Huningue , Grand Est
Are you ready to join a world leader in the excitingand dynamic fields of the Pharmaceutical and Medical Deviceindustries? PQE Group has been at the forefront of these industriessince 1998, with 40 subsidiaries and more than 2000 employees inEurope, Asia, and the Americas. Job Overview Due to our continuousgrowth, we are looking for a Cleaning Validation Consultant tosupport activities related to process validation and cleaningvalidation within a GMP-regulated pharmaceutical manufacturingenvironment. The consultant will be responsible for drafting andexecuting validation protocols, performing risk assessments, andmanaging related documentation in compliance with regulatorystandards. Responsibilities: - Draft and execute Process ValidationProtocols (IQ/OQ/PQ) in compliance with current GMP and internalvalidation master plans. - Develop and implement CleaningValidation protocols, ensuring compliance with product carryoverlimits and cleaning procedures. - Perform risk assessments (e.g.,FMEA) to evaluate process and product-related risks. - Write andreview validation reports, SOPs, and supporting documentation inaccordance with regulatory and internal quality standards. -Coordinate validation activities with production, qualityassurance, engineering, and other relevant departments. - Supportongoing lifecycle validation by identifying gaps and contributingto continuous improvement initiatives. Qualifications: - Mastersdegree in Pharmaceutical Sciences, Chemistry, or a relatedscientific discipline (5 years of higher education). - At least 1year of experience (including internships or apprenticeships) invalidation or QA qualification in a pharmaceutical GMP environment.- Solid understanding of EU GMP requirements, including Annex 15(Qualification and Validation). - Strong knowledge of processvalidation principles, cleaning validation strategies, anddocumentation best practices. - Excellent organizational andcoordination skills; ability to manage activities across multipledepartments. - Proficient in Microsoft Office (Word, Excel,PowerPoint). - Knowledge of galenic forms (oral solids, liquids,injectables, etc.) is an asset. - Fluent in English (spoken andwritten); French is a plus depending on the site environment. NextSteps Upon receiving your application, if a match is found, theRecruiting department will contact you for an initial HR interview.If there''s a positive match, a technical interview with the HiringManager will be arranged. In the case of a positive feedback comingfrom the Hiring Manager interview, the recruiter will contact youfor the next steps or to discuss our proposal. Alternatively, ifthe feedback is negative, we will contact you to halt therecruitment process. Working at PQE Group As a member of the PQEteam, you will be part of a challenging, multicultural company thatvalues collaboration and innovation. PQE Group gives you theopportunity to work on international projects, improve your skillsand interact with colleagues from all corners of the world. If youare looking for a rewarding and exciting career, PQE Group is theperfect place for you. Apply now and take the first step towards anamazing future with us.