Quality Assurance Specialist

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

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are currently seeking an experienced Quality Assurance Specialist in Spain. Responsible for batch release, GMP compliance, quality systems management, supplier oversight, audit support, and continuous improvement initiatives to ensure product quality and regulatory compliance.

Please note: Although the primary location for this role is Madrid, the selected candidate will be required to work 100% on site in Azuqueca de Henares (Madrid) for the duration of the project.

Responsibilities include:

• Review and approve batch records, specifications, analytical data, and release documentation for raw materials, packaging components, APIs, bulk and finished products.
• Support batch release activities, including assessment of deviations, OOS/OOT, non-conformities, and approval/rejection of batches and materials in SAP.
• Manage and maintain GMP quality systems, including SOPs, change controls, CAPAs, complaints, investigations, quality agreements, and GMP documentation.
• Prepare and maintain APR/PQRs and support quality trend analysis, stability activities, and retention sample management.
• Support supplier qualification and audits, equipment/process/cleaning qualification and validation, and microbiological and environmental monitoring activities.
• Participate in internal and external audits, customer audits, and regulatory inspections, supporting GMP compliance and inspection readiness.
• Collaborate with Production, QC, Engineering, Regulatory Affairs, and other functions to ensure compliance with GMP requirements.
• Support the Qualified Person (QP) and contribute to quality investigations, recalls, and continuous improvement activities.

Requirements:

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