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:

- Review and approve batch records, specifications, analytical data, and release documentation for raw materials, packaging components, APIs, bulk and finished products.
- Support batch release activities, including assessment of deviations, OOS/OOT, non-conformities, and approval/rejection of batches and materials in SAP.
- Manage and maintain GMP quality systems, including SOPs, change controls, CAPAs, complaints, investigations, quality agreements, and GMP documentation.
- Prepare and maintain APR/PQRs and support quality trend analysis, stability activities, and retention sample management.
- Support supplier qualification and audits, equipment/process/cleaning qualification and validation, and microbiological and environmental monitoring activities.
- Participate in internal and external audits, customer audits, and regulatory inspections, supporting GMP compliance and inspection readiness.




- Collaborate with Production, QC, Engineering, Regulatory Affairs, and other functions to ensure compliance with GMP requirements.
- Support the Qualified Person (QP) and contribute to quality investigations, recalls, and continuous improvement activities.

Requirements:

- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related scientific field.
- Approximately 3 years of experience in Quality Assurance within a GMP-regulated pharmaceutical environment.
- Good knowledge of GMP requirements and pharmaceutical quality systems.
- Experience with batch release and quality documentation.
- Strong analytical, organizational, and communication skills.
- Native-level Spanish proficiency (mandatory); Fluent English

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 - PQE Group (Madrid)
🏢 Pqe Group
📍 Madrid