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Global qa specialist, ivd diagnostics – hybrid role (xàtiva)

Xàtiva
Grifols
Publicada el 27 abril
Descripción

NEW OPPORTUNITY – Temporary QA Specialist (Pharma)On-site | Sant Cugat (Barcelona)Contract: End May 2026 – December 2026Oxford Global Resources – Life Sciences Unit is supporting one of the fastest-growing pharmaceutical companies headquartered in Spain, recognized for its strong commitment to innovation and R&D excellence.We are currently looking for an experienced QA R&D Specialist to join their Quality Assurance – Pharmaceutical Development team on a temporary basis.Role: QA Specialist – R&D (GMP, IMPs, Quality Systems)Location: Sant Cugat (on-site)Start: ASAP | Full-time, long-term projectExperience: Minimum 3–4 years in a similar QA R&D GMP roleSector: Pharmaceutical | GxP | Clinical Trials | IMPsMain ResponsibilitiesReview and/or approval of key GMP documentation generated by the Pharmaceutical Development area, including:Manufacturing, packaging, and labeling instructions for IMPsAnalytical methods, specifications (LIMS), and specification dossiersICH stability protocols/reportsMethod validation documentationShelf-life justification reports for IMPsDeviation and change control managementMaster Manufacturing Plans (MMP & MMPr)SOPs for equipment cleaning, operations, and room proceduresQualification protocols/reports for analytical equipmentSupport the Quality Management System (QMS):Deviation handling, CAPAs, change controls, complaintsInvestigations of OOS, OOE, OOT and related CAPA evaluationEdition and maintenance of Quality AgreementsSOPs and controlled documents related to Quality & R&DArchiving and documentation management for GxP-relevant activitiesMonitor the status of IMPs throughout the clinical supply chain (manufacturing to end-of-trial)Participate in audits (internal/external) and inspectionsManage submissions to AEMPS as needed (manufacturing/import/export, controlled substances)Your ProfileBachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or similar3–5 years of experience in QA within an R&D or IMPs-focused GMP environmentSolid knowledge of ICH, GxP, EU GMP Annex 13Experience working closely with manufacturing, analytical, and regulatory teamsSpanish required; English professional levelTeam player with attention to detail and problem-solving mindsetWhat's in it for you?Join a highly dynamic team in a company with a strong pipeline and innovative product portfolioWork on-site in Sant Cugat, in close collaboration with R&D, QA, and Regulatory teamsBe part of a mission-driven, growth-oriented pharma companyInterested?Apply now or reach out to our Life Sciences team at Oxford Integral Resources to learn more:#LifeSciences #GMP #QAJobs #IMPs #PharmaJobs #SantCugat #BarcelonaJobs #OxfordGlobalResources

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Inicio > Empleo > Global Qa Specialist, Ivd Diagnostics – Hybrid Role (Xàtiva)

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