Quality Assurance Specialist: GMP Release & Audit Lead

PQE Group; Madrid; Presencial; EUR 42.000 - 52.000; Jornada completa

Descripción de la vacante

PQE Group in Madrid is seeking an experienced Quality Assurance Specialist to ensure batch release, GMP compliance, and robust quality systems across the pharmaceutical and medical device domains.

The role emphasizes collaboration with multiple functions to uphold regulatory standards and continuous improvement, with the position based on-site in Madrid and the requirement to work 100% on-site in Azuqueca de Henares (Madrid).

Formación

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 3 years of Quality Assurance experience in GMP-regulated pharma.
• Good knowledge of GMP requirements and pharmaceutical quality systems.
• Experience with batch release and quality documentation.
• Strong analytical, organizational, and communication skills.

Responsabilidades

• Review and approve batch records, specs, analytical data, and release docs for materials and products.
• Support batch release activities and assess deviations, OOS/OOT, non-conformities, and approvals in SAP.
• Maintain GMP quality systems, including SOPs, change controls, CAPAs, complaints, investigations, and quality agreements.
• Prepare APR/PQRs and support trend analysis, stability activities, and retention sample management.
• Assist in supplier qualification, audits, qualification/validation activities, and monitoring.

Conocimientos

GMP knowledge

Batch release

Quality documentation

Analytical skills

Organizational skills

Communication skills

Educación

Bachelor’s degree in Pharmacy/ Chemistry/ Life Sciences

Descripción del empleo

PQE Group in Madrid is seeking an experienced Quality Assurance Specialist to ensure batch release, GMP compliance, and robust quality systems across the pharmaceutical and medical device domains.

The role emphasizes collaboration with multiple functions to uphold regulatory standards and continuous improvement, with the position based on-site in Madrid and the requirement to work 100% on-site in Azuqueca de Henares (Madrid).