offre-emploi


Cleaning Validation Consultant > PQE Group > Joboolo FR :


Société : PQE Group
Lieu : Huningue 68330

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.


Job Overview

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.


Responsibilities:



  • 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.



  • Perform risk assessments (e.g.,
    FMEA) to evaluate process and product-related risks.



  • 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.


Qualifications:



  • Master’s 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.



  • Excellent organizational and coordination skills; ability to manage activities across multiple departments.



  • Proficient in Microsoft Office (Word, Excel, PowerPoint).



  • Knowledge of galenic forms (oral solids, liquids, injectables, etc.) is an asset.



  • Fluent in English (spoken and written); French is a plus depending on the site environment.


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.



PQE Group
Huningue 68330
Autre(s)
Stage
0 mois





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