Quality Assurance Specialist

buscojobs España; Albacete; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Une entreprise dynamique dans le secteur pharmaceutique recherche un QA Specialist pour maintenir et améliorer son système de gestion de la qualité. Le candidat idéal aura une expérience en environnement GMP et sera responsable de garantir la conformité aux normes de qualité et réglementaires. Ce poste offre des opportunités de collaboration avec diverses équipes et de participation à des initiatives d'amélioration continue.

Formación

• 2+ ans d'expérience en QA dans un environnement réglementé GMP.
• Maîtrise des réglementations EU GMP et FDA.
• Bilingue en anglais et espagnol.

Responsabilidades

• Support des opérations QA quotidiennes, y compris révisions de dossiers.
• Participation aux audits internes et externes.
• Collaboration avec les équipes de production et R&D.

Conocimientos

Connaissance des GMP

Compétences en communication

Résolution de problèmes

Organisation

Educación

Baccalauréat ou Master en Pharmacie, Chimie, Biotechnologie

Herramientas

Outils QMS

Systèmes de documentation électronique

Descripción del empleo

As a QA Specialist , you will play a key role in maintaining and enhancing the Quality Management System (QMS) of our CDMO operations in Barcelona. You will ensure compliance with GMP, regulatory requirements, and internal quality standards across development and manufacturing processes for our clients in the pharmaceutical / biotech sector.

Key Responsibilities :

• Support daily QA operations including batch record review, deviation investigations, change control, and CAPA management
• Ensure compliance with GMP guidelines and applicable international regulations (EMA, FDA, ICH, etc.)
• Participate in internal and external audits (regulatory and client-based)
• Collaborate with production, QC, R&D, and regulatory affairs teams to ensure alignment on quality objectives
• Review and approve quality documentation including SOPs, validation protocols, and specifications
• Support product release activities and liaise with Qualified Persons (QPs) as needed
• Contribute to continuous improvement initiatives and risk assessments within QA
• Assist in training programs for QA procedures and GMP awareness across departments
• Support QA oversight for technology transfer and new product introductions

Qualifications :

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or related life science discipline
• 2+ years of experience in a QA role within a GMP-regulated environment (preferably CDMO, pharma, or biotech)
• Strong knowledge of EU GMP and understanding of FDA regulations
• Experience with QMS tools and electronic documentation systems
• Fluent in English and Spanish (both written and spoken)
• Strong communication, organization, and problem-solving skills
• Ability to work both independently and as part of a cross-functional team

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