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Qa support consultant

Barcelona
PQE Group
Publicada el Publicado hace 17 hr horas
Descripción

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.As part of our ongoing growth and commitment to excellence, we are currently looking for a QA Support Consultant with solid experience in the pharmaceutical industry to support validation activities for a new oral solid dosage (OSD) production line handling high-potency APIs (OEB 5).The ideal candidate has hands-on experience in granulation production lines, is proficient in Veeva software, and is capable of supervising qualification protocols. Please note: Although the primary location for this role is Barcelona, for approximately the first 6 months the selected candidate will be required to work 100% on-site in Riells i Viabrea.Responsibilities include, but are not limited to:Drafting and reviewing the Validation Master Plan (VMP)Supervising and verifying all qualification protocols: DQ, IQ, OQ, PQEnsuring all acceptance criteria are defined and verified both before and after testingSupporting Performance Qualification (PQ) for purified and industrial water systems (focus on added Points of Use rather than a new loop)Conducting risk analysis and selecting environmental monitoring locations in ISO8 cleanroomsEnsuring compliance with GMP and internal quality standardsManaging documentation and workflows using Veeva softwareRequired Qualifications:Proven experience with granulation production lines in GMP-regulated environmentsSolid knowledge of qualification and validation processes for OSD productionExperience using Veeva softwareAvailable 100% to be onsite in Riells i ViabreaFluent in Spanish and professional-level EnglishExperience with high-potency APIs (OEB 5)Knowledge of cleanroom qualification and environmental monitoring strategiesPrevious consultancy work in international pharmaceutical settingsFamiliarity with hybrid project environmentsNext StepsUpon 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 outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs 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.

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