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 GM

📌 Quality Assurance Specialist (Castilla y León)
🏢 Pqe Group
📍 Castilla y León