Global QA Specialist — GxP, Pharma, International Scope

Exeltis; Madrid; Presencial; EUR 35.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits and Savings Club

Training and language learning平台

Wellness platform with psychologist

Development plans and internalMobility

Descripción de la vacante

Exeltis is seeking a Quality Assurance Specialist to ensure GxP, regulatory, and internal standards compliance across markets within the Insud Pharma group. The role involves managing quality activities for products with Exeltis Marketing Authorizations and supporting MAH in meeting local regulatory requirements.

Ideal candidates have 2+ years in QA or Quality Systems, knowledge of cGDPs/cGMPs, and fluency in English and Spanish. Travel may be required.

Formación

• University degree in pharmacy or equivalent is required.
• Fluent English and Spanish are essential.
• At least 2 years in QA or quality systems in distribution centers, affiliates, or manufacturing sites.
• Knowledge of cGDPs and cGMPs is preferred.
• Knowledge of Quality for Marketing Affiliate is desirable.
• Good command of Microsoft Office.

Responsabilidades

• Ensure compliance with GxP, regulatory, and internal standards.
• Manage quality activities for products marketed under Exeltis MAHs.
• Support handling of complaints, deviations, PQRs, recalls, and quality agreements.
• Support MAH compliance with local legislation in markets where products are marketed.
• Establish, implement, and maintain quality systems in each market.
• Provide oversight to support regulatory requirements and continuous improvement.

Conocimientos

Quality Assurance

Quality Systems

Regulatory compliance

Educación

University Degree in Pharmacy

Medium Diploma in Pharmacy

Master’s degree in Pharmaceutical Industry

Herramientas

Microsoft Office

Descripción del empleo

Exeltis is seeking a Quality Assurance Specialist to ensure GxP, regulatory, and internal standards compliance across markets within the Insud Pharma group. The role involves managing quality activities for products with Exeltis Marketing Authorizations and supporting MAH in meeting local regulatory requirements.

Ideal candidates have 2+ years in QA or Quality Systems, knowledge of cGDPs/cGMPs, and fluency in English and Spanish. Travel may be required.