QA R&D Specialist – GMP/IMPs in Pharma Development

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

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.