18 sep
|
Oxford Global Resources
|
San Cugat del Vallés
18 sep
Oxford Global Resources
San Cugat del Vallés
NEW OPPORTUNITY – Temporary QA R&D; Specialist (Pharma) 4-5 meses On-site | Sant Cugat (Barcelona)
Por favor, verifique que tiene el nivel de experiencia y las cualificaciones adecuadas leyendo la descripción completa de esta oportunidad a continuación.
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
📌 Quality Assurance Officer R temporal (San Cugat del Vallés)
🏢 Oxford Global Resources
📍 San Cugat del Vallés