Quality Assurance Officer R&D temporal
Contract: End August 2026 – December 2026
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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)
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 xcskxlj 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?
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