17 sep
|
Oxford Global Resources
|
Tarragona
17 sep
Oxford Global Resources
Tarragona
? 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 | IMPsMain 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 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 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, 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 mindsetWhat’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#J-18808-Ljbffr
📌 Quality Assurance Officer R&D Temporal (Tarragona)
🏢 Oxford Global Resources
📍 Tarragona