22 sep
|
Oxford Global Resources
|
San Cugat del Vallés
22 sep
Oxford Global Resources
San Cugat del Vallés
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)
Sector: Pharmaceutical | GxP | Clinical Trials | IMPs
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
- Shelf-life justification reports for IMPs
- Deviation and change control management
- SOPs for equipment cleaning, operations, and room procedures
- Qualification protocols/reports for analytical equipment
Support the Quality Management System (QMS):
- 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)
- 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
📌 Quality Assurance Officer R&D temporal (San Cugat del Vallés)
🏢 Oxford Global Resources
📍 San Cugat del Vallés