22 sep
|
Oxford Global Resources
|
Madrid
22 sep
Oxford Global Resources
Madrid
NEW OPPORTUNITY – Temporary QA R&D; Specialist (Pharma) 4-5 meses On-site | Sant Cugat (Barcelona) Contract: End August 2026 – December 2026Oxford Integral 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 |
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Full-time, long-term project Experience: Minimum 2-3 years in a similar QA R&D; GMP role Sector: Pharmaceutical | GxP | Clinical Trials | IMPs Main Responsibilities Review 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 equipment Support 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 activities Monitor the status of IMPs throughout the clinical supply chain (manufacturing to end-of-trial) Participate in audits (internal/external) and inspections Manage submissions to AEMPS as needed (manufacturing/import/export, controlled substances)
📌 Quality Assurance Officer R&D Temporal (Madrid)
🏢 Oxford Global Resources
📍 Madrid