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