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.

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-cause investigations, and trend analysis activities.
Oversee document control processes, including issuance, distribution, archival, and management of controlled GMP documentation.
Support GMP training programs and pro

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