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:

Release & Product Disposition
- Review and approve specifications for APIs, raw materials, packaging components, bulk products, and finished products.
- Review and approve batch records, analytical results, and release documentation in compliance with GMP requirements and internal procedures.




- Approve or reject raw materials, packaging materials, bulk, and finished product batches in SAP.
- Issue and approve Certificates of Analysis (CoA) and release documentation for commercial and regulatory purposes.
- Monitor and assess deviations, non-conformities, OOS/OOT investigations, and related quality events affecting batch disposition.
- Maintain master batch records and ensure compliance with marketing authorizations and regulatory requirements.
- Review stability protocols, retention samples, and stock-control status to support product release decisions.
- Support customer requests, quality technical agreements, product registration activities, and supplier complaint management.

Quality Systems & Compliance
- Develop, review, and approve SOPs and GMP documentation to ensure compliance with internal standards and applicable regulations.
- Manage Change Controls, CAPAs, deviations, complaints, root

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