Descripción de la oferta
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.Our values:PEOPLE-CENTRIC: We put people at the centre of everything we do.SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared success.CURIOUS PEOPLE: We continuously learn and innovate, valuing the unique experience and perspectives that each person brings to the organisation.ABOUT THE JOBWe 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.MissionTo 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.The position will also contribute to the implementation of the actions required to maintain a continuous improvement approach in accordance with the company’s guidelines and objectives.Main Tasks and ResponsibilitiesPrepare, 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.Participate in the GMP qualification of equipment and facilities.Provide Quality Assurance oversight of analytical method validation activities, including the review of validation plans, protocols and reports.Collaborate in the review of validation activities related to manufacturing processes and cleaning procedures, where applicable.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.Collaborate in the supplier qualification process, managing the information received and supporting supplier classification according to established approval levels.Collaborate with the IT/UI department to ensure compliance with 21 CFR Part 11 and EU GMP Annex 11, including computerised system validation and support in the selection of new equipment or systems.Ensure Data Integrity principles are applied to data used for decision-making in GxP and business environments.REQUIREMENTSUniversity degree in Biochemistry, Biotechnology, Pharmacy, Chemistry or a related scientific discipline.At least 2 years of professional experience in a GMP-regulated pharmaceutical laboratory, preferably in Quality Assurance/Quality Control or Analytical Development.Practical experience in the review of analytical results and investigation of OOS and/or deviations.Experience in analytical method validation.Experience working under EU GMP requirements.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 biological products, allergen immunotherapy products and/or sterile products.Experience with CAPAs, Change Controls, PQRs and GMP documentation.Knowledge of 21 CFR Part 11, EU GMP Annex 11 and Data Integrity principles.REMUNERATIONAccording to the Company Agreement (Category 6 of the Chemical Industry Collective Agreement).PROFILEWe 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 ideal 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.
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