Nuestro cliente es una compañía biofarmacéutica especializada en inmunoterapia con alérgenos, orientada al diagnóstico y tratamiento de las enfermedades alérgicas, con una sólida trayectoria industrial y una clara apuesta por la calidad, la innovación y la excelencia operativa. Su planta productiva, ubicada en Leganés (Madrid), opera bajo los más altos estándares regulatorios y de cumplimientonormativo, alineados con las exigencias internacionales del sector farmacéutico. La compañía cuenta con presencia en cerca de 40 países, con foco estratégico en los mercados de EMEA y APAC, donde está iImpulsando su crecimiento y la expansión general de su portfolio.

MISSION ·Ensure that the products and services produced are in accordance, manufactured, controlled and distributed in accordance with the Correct Manufacturing Standards and with the Quality specifications established for each of them by the Company and authorized by the corresponding health authorities. ·Review and approval of batch documentation (manufacturing and analytical) and release to the market of pharmaceutical and health products. ·Ensure that the processes carried out in the Madrid warehouse are carried out in accordance with current regulations.

KEY RESPONSIBILITIES Technical Functions ·Quality Guarantee Release: ··Ensure compliance with the quality systems implemented to guarantee the conformity of the batches released on the market. ··Release to the market of pharmaceutical and health products as Technical Director/Qualified person (QP).

Responsibility according to regulations. ··Guarantee that all necessary tests are carried out to guarantee the quality of the products and services carried out at Madrid. ··Directly or by delegation,



evaluate the protocols of each batch of semi-finished or finished product manufactured at Madrid for approval and release by qualified persons.

··Estimate and evaluate the actions that may affect the quality of products and services in their area of ¿¿responsibility. ··Ensure and guarantee the implementation and application of the quality management system, NCF, ISO 13.485, ISO 9001, the SOPs in their area of ¿¿responsibility. ··Together with Quality Assurance Manager substitute the Director of Quality in his absence, if required, by delegation of functions.

··Manage the system of deviations and quality incidents, ensuring that they are dealt with effectively. ··Participate in the development of corrective and preventive action plans linked to Quality incidents, ensuring their implementation and monitoring. External relationships

··Participate directly or indirectly in the inspections of the health authorities and the audits carried out by external organizations and the audits of clients. ··Participate in product recalls and pharmaceutical alerts of products manufactured in Madrid, ensuring compliance with the procedure in their area of ¿¿activity

Main professional relationships: ··Hierarchical/functional unit: Head of Quality Management ··Internal: Rest of the Plant's departments, corporate units, other business units.

Requirements and experiences ·Training: Bachelor's Degree in Health Sciences (Pharmacy, Chemistry, Biology, etc.), valuing complementary training in Quality Control and Quality Assurance. ·Languages ¿¿(Language and proficiency level): high level of English.

·Professional Experience: 5 years in a similar position preferably in the pharmaceutical sector. ·Additional knowledge: ·In-depth knowledge of the Correct Manufacturing Standards. ·Specific training in Quality Standards for the pharmaceutical sector.

·Complementary training in quality system audits, validation activities, ISO quality systems.

📌 Deputy QP Anexo 1 esteriles (Madrid)
🏢 OPTIMAES TALENT SEARCH
📍 Madrid