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 provide guidance on quality compliance matters.
- Support validation and qualification activities related to manufacturing processes, cleaning procedures, equipment, and utilities.
- Prepare and review Annual Product Reviews (APR/PQR) and other quality system reports.

Audits, Suppliers & Continuous Improvement
- Conduct internal audits and support customer, supplier, and regulatory inspections.
- Participate in supplier qualification, certification, performance monitoring, and audit activities.
- Review environmental, microbiological, temperature, and pressure monitoring data to ensure GMP compliance.
- Support quality investigations, recalls, and Qualified Person (QP) activities.
- Manage quality relationships with suppliers and third parties, ensuring compliance with technical and quality agreements.
- Act as a subject matter expert by training and mentoring new team members on quality processes and GMP requirements.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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