We are dedicated to the research, development, manufacture and distribution of allergen immunotherapy products , contributing to improving the quality of life of patients worldwide through innovative healthcare solutions. Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio, where our manufacturing site is also based. As part of our growth and expansion plans, we are looking for talented professionals committed to quality, innovation and continuous improvement.

We are looking for a Quality Assurance Technician with a strong specialisation in Quality Control to join our team and continue developing professionally with us. The successful candidate will report to the Head of the Quality Assurance Unit , within the Technical Directorate. To ensure compliance with Roxall’s Quality Management System (QMS) and with applicable GMP, GDP, regulatory and legal requirements , with a particular focus on Quality Control activities, analytical results and analytical method validation .

Prepare, review or supervise Quality Management System (QMS) procedures and documentation , particularly documentation related to Quality Control activities. Review analytical results and participate in the investigation of Out-of-Specification (OOS) results, deviations and other quality events , as well as in the definition and follow-up of Corrective and Preventive Actions (CAPAs) . Participate in the preparation and review of Product Quality Reviews (PQRs) .

Collaborate in the evaluation and follow-up of Change Controls .

Provide Quality

Assurance oversight of analytical method validation activities , including the review of validation plans,



protocols and reports. Review manufacturing batch records and Quality Control documentation . Train company personnel in Quality Management and GMP requirements .

Collaborate with the Head of the Quality Assurance Unit to promote GMP compliance and propose improvements to the Quality Management System. Support different organisational units in the implementation and maintenance of approved procedures, promoting continuous improvement, quality risk management, contamination prevention and compliance with applicable regulatory requirements .

Ensure Data

Integrity principles are applied to data used for decision-making in GxP and business environments. At least 2 years of professional experience in a GMP-regulated pharmaceutical laboratory , preferably in Quality Assurance/Quality Control or Analytical Development . Knowledge of Quality Systems and applicable ICH Guidelines .

Fluent

English, both written and spoken, minimum C1 level or equivalent. Additional training in Pharmaceutical Quality Control, Analytical Validation and/or Quality Assurance .

Experience with CAPAs, Change Controls, PQRs and GMP documentation . Knowledge of 21 CFR Part 11, EU GMP Annex 11 and Data Integrity principles . We are looking for an analytical, rigorous and results-oriented professional who is comfortable working cross-functionally with Quality Assurance, Quality Control, R&D; and other technical areas.

The adecuado candidate will combine a strong scientific and analytical background with a clear commitment to GMP compliance, analytical quality, robust documentation, investigation of quality events and continuous improvement .

📌 Quality Assurance Technician - QC & Analytical Validation (Bilbao)
🏢 Roxall Medicina España
📍 Bilbao