Quality Assurance Specialist

Pqe Group; Madrid; Presencial; EUR 42.000 - 54.000; Jornada completa

Descripción de la vacante

PQE Group in Madrid seeks an experienced Quality Assurance Specialist in Spain to ensure batch release, GMP compliance, and continuous improvement across QA systems.

You will review records, support audits, manage quality documentation, and collaborate with Production, Regulatory Affairs, and QC to maintain inspection readiness.

Formación

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

GMP

Analytical skills

Communication skills

Audits

Educación

Bachelor’s degree in Pharmacy, Chemistry, Life Sciences

Herramientas

SAP

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.