21 sep
|
Oxford Global Resources
|
España
21 sep
Oxford Global Resources
España
NEW OPPORTUNITY – Temporary QA R& D Specialist (Pharma) 4-5 meses Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud después de leer la descripción completa. On-site | Sant Cugat (Barcelona) Contract: End August 2026 – December 2026 Oxford 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 project Experience: Minimum 2-3 years in a similar QA R& D GMP role Sector: Pharmaceutical | Gx P | 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 IMPs Analytical methods, specifications (LIMS), and specification dossiers ICH stability protocols/reports Method validation documentation Shelf-life justification reports for IMPs Deviation and change control management Master Manufacturing Plans (MMP & MMPr) SOPs for equipment cleaning, operations, and room procedures Qualification protocols/reports for analytical equipment Support the Quality Management System (QMS):
Deviation handling, CAPAs, change controls, complaints 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 Gx P-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 Profile 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, Gx P, xohynlm 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? Apply now or reach out to our Life Sciences team at Oxford Global Resources to learn more: #Life Sciences #GMP #QAJobs #IMPs #Pharma Jobs #Sant Cugat #Barcelona Jobs #Oxford General Resources
📌 Quality Assurance Officer R&D Temporal (España)
🏢 Oxford Global Resources
📍 España