NEW OPPORTUNITY – Temporary QA R&D Specialist (Pharma)No espere a enviar su solicitud después de leer esta descripción; se espera un gran volumen de candidaturas para esta oportunidad.
On-site | Sant Cugat (Barcelona)
Contract: End May 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.
RoleQA Specialist – R&D (GMP, IMPs, Quality Systems)
Location: Sant Cugat (on-site)
Start: ASAP | Full-time, long-term project
Experience: Minimum 3–4 years in a similar QA R&D GMP role
Sector: Pharmaceutical | GxP | Clinical Trials | IMPs
Main ResponsibilitiesReview 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
3–5 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?
Apply now or reach out to our Life Sciences team at Oxford Global Resources to learn more.
#LifeSciences #GMP #QAJobs #IMPs #PharmaJobs #SantCugat #BarcelonaJobs #OxfordGlobalResources
#J-18808-Ljbffr