17 sep
|
Oxford Global Resources
|
Madrid
17 sep
Oxford Global Resources
Madrid
NEW OPPORTUNITY – Temporary QA R&D; Specialist (Pharma) 4-5 meses
On-site | Sant Cugat (Barcelona) Contract: End August 2026 - December 2026
Oxford 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 | 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 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 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
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📌 Quality Assurance Officer R&D Temporal (Madrid)
🏢 Oxford Global Resources
📍 Madrid