06 oct
|
Oxford Global Resources
|
Barcelona
06 oct
Oxford Global Resources
Barcelona
Contract: End August 2026 – December 2026 Oxford 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) Sector: Pharmaceutical | GxP | Clinical Trials | IMPs Review and/or approval of key GMP documentation generated by the Pharmaceutical Development area, including: * Manufacturing, packaging, and labeling instructions for IMPs * Analytical methods, specifications (LIMS), and specification dossiers * ICH stability protocols/reports * Shelf-life justification reports for IMPs * Deviation and change control management * SOPs for equipment cleaning, operations, and room procedures * Qualification protocols/reports for analytical equipment Support the Quality Management System (QMS): * Investigations of OOS, OOE,
OOT and related CAPA evaluation * Edition and maintenance of Quality Agreements * SOPs and controlled documents related to Quality & R&D; * Archiving 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) * Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or similar * 2-3 years of experience in QA within an R&D; or IMPs-focused GMP environment * Solid knowledge of ICH, GxP, EU GMP Annex 13 * Experience working closely with manufacturing, analytical, and regulatory teams * Spanish required; English professional level * Team player with attention to detail and problem-solving mindset What’s in it for you? Join a highly dynamic team in a company with a strong pipeline and innovative product portfolio Work on-site in Sant Cugat, in close collaboration with R&D;, QA, and Regulatory teams Be part of a mission-driven, growth-oriented pharma company Interested? #J-18808-Ljbffr
📌 Quality Assurance Officer R&D temporal (Barcelona)
🏢 Oxford Global Resources
📍 Barcelona