30 ago
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Pqe Group
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Madrid
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.
Asegúrese de presentar su candidatura con toda la información solicitada, tal como se expone en la descripción del puesto a continuación.
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
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- 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
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- Develop, review, and approve SOPs and GMP document
📌 Quality Assurance Specialist (Madrid)
🏢 Pqe Group
📍 Madrid