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Qa specialist - end-to-end & ui automation expert (les)

Les
Alten
Publicada el 11 abril
Descripción

NEW OPPORTUNITY – Temporary QA Specialist (Pharma)

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On-site | Sant Cugat (Barcelona)

Contract: End May 2026 – December 2026

Oxford Integral 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 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, xhfqzwm 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

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