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.

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📌 Quality Assurance Specialist (Madrid)
🏢 Pqe Group
📍 Madrid