17 sep
|
Oxford Global Resources
|
Gerona
17 sep
Oxford Global Resources
Gerona
? NEW OPPORTUNITY – Temporary QA R&D; Specialist (Pharma) 4-5 meses A continuación se detalla todo lo que necesita saber sobre lo que implica esta posibilidad, así como lo que se espera de los solicitantes.
? On-site | Sant Cugat (Barcelona)
? Contract: End August 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.
? 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 xugodme 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
📌 Quality Assurance Officer R&D temporal (Gerona)
🏢 Oxford Global Resources
📍 Gerona