Quality Assurance Officer R&D

Descripción del empleo

NEW OPPORTUNITY – QA R&D Specialist (Pharma) | On-site – Sant Cugat, Barcelona

Oxford Global Resources – Life Sciences Unit is currently supporting one of the fastest-growing pharmaceutical companies headquartered in Spain, with a strong focus on innovation and R&D.

We are looking for an experienced QA professional to join their Quality Assurance – Pharmaceutical Development team.

Role: QA Specialist – R&D (GMP, IMPs, Quality Systems)

Location: Sant Cugat (on-site)

Start: ASAP | Full-time, long-term project

Experience: Minimum 3–4 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
• 3–5 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?

Apply now or reach out to our Life Sciences team at Oxford Global Resources to learn more:

#LifeSciences #GMP #QAJobs #IMPs #PharmaJobs #SantCugat #BarcelonaJobs #OxfordGlobalResources

Información extra

Status

Inactiva

Estudios requeridos

E.S.O

Localización

Sant Cugat del Vallès

Tipo de contrato

Trabajo estudiantes

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español