Quality Assurance Officer R&D temporal

Oxford Global Resources; Sant Cugat del Vallès; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Oxford Global Resources – Life Sciences Unit is seeking an experienced QA R&D Specialist to join the Quality Assurance – Pharmaceutical Development team on a temporary basis in Spain.

You will review and approve GMP documentation for IMPs, management of quality systems, OOS/OOE investigations, and CAPA, and support AEMPS submissions while collaborating with manufacturing, analytical, and regulatory teams to uphold GxP compliance.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

QA

GMP

GxP

ICH guidelines

Regulatory collaboration

Bilingual Spanish/English

Educación

Bachelor’s or Master’s in Pharmacy/Chemistry/Biotechnology

Herramientas

LIMS

Descripción del empleo

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)

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 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

Interested?