10 sep
|
Oxford Global Resources
|
España
10 sep
Oxford Global Resources
España
? 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 | ? 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)✅ Your ProfileBachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or similar2-3 years of experience i
📌 Quality Assurance Officer R&D Temporal (España)
🏢 Oxford Global Resources
📍 España