09 sep
|
Oxford Global Resources
|
Madrid
09 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 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 simil
📌 Quality Assurance Officer R&D temporal (Madrid)
🏢 Oxford Global Resources
📍 Madrid