Quality Assurance Specialist

AL Solutions; Gijón; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A leading CDMO is seeking a QA Specialist to oversee and enhance the Quality Management System for pharmaceutical operations in Barcelona. The role involves ensuring compliance with regulatory standards and collaborating across departments to maintain high-quality standards in production and development processes. Candidates should possess a relevant degree and have a robust experience in a GMP environment, fluent in English and Spanish.

Formación

• 2+ years of experience in a QA role within a GMP-regulated environment.
• Strong knowledge of EU GMP and FDA regulations.
• Fluent in English and Spanish (written and spoken).

Responsabilidades

• Support daily QA operations including batch record review and CAPA management.
• Ensure compliance with GMP guidelines and participate in audits.
• Collaborate with cross-functional teams to ensure quality objectives.

Conocimientos

Communication

Organization

Problem-Solving

Educación

Bachelor’s or Master’s degree in Pharmacy

Bachelor’s or Master’s degree in Chemistry

Bachelor’s or Master’s degree in Biotechnology

Degree in related life science discipline

Herramientas

QMS tools

Electronic documentation systems

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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