NEW OPPORTUNITY – QA R&D Specialist (Pharma) | On-site – Sant Cugat, Barcelona Oxford Global Resources – Life Sciences Unit is currently supporting one of the fastest-growing pharmaceutical companies headquartered in Spain, with a strong focus on innovation and R&D. We are looking for an experienced QA professional to join their Quality Assurance – Pharmaceutical Development team.
Role:
QA 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 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 * 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:
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