Qualified Person & Quality Assurance en Inizio Engage Qualified Person & Quality Assurance Inizio Engage | (22) ofertas activas Inizio es un partner estratégico dentro del sector Health & Life Sciences. En Inizio Engage, reunimos una serie de capacidades que incluyen advanced analytics, experience design, medical affairs, patient solutions and comercial. Gracias a nuestra combinación única de experiencia en asesoramiento, creación y activación con la tecnología más avanzada, diseñamos y ofrecemos soluciones a medida que inspiran un cambio duradero.Nuestra misión es mejorar la vida de los pacientes a través de la colaboración y el trabajo constante que nuestros equipos realizan con los profesionales de la salud.Actualmente, buscamos profesionales con talento, ganas de aprender y contribuir ¿Estás listo para dar un nuevo paso en tu carrera profesional? ¡Te esperamos! https://inizio.health/ Madrid 28 May. - - Descripción In Inizio Engage, we are recruiting for a direct and permanent position in a significant laboratory in Madrid, a Qualified Person & Quality Assurance (GDP activities) profile.What would be your main responsibilities?- Ensure local compliance with pharmaceutical regulations and legislation as the Qualified Person (QP), overseeing GDP achievements by the company and subcontractors.- Develop and maintain an effective Pharmaceutical Quality Management System (QMS) to align with EU GMP, GDP, GVP, and Corporate Quality Guidelines.- Collaborate with the Head of Affiliate to optimize departmental efficiency while ensuring compliance with relevant legislation.- Serve as the Responsible Person (RP) and RP (Import), personally fulfilling RP responsibilities.- Provide strategic input for business development, new product introductions, and local commercialization efforts.- Manage the workload, personal development of quality staff, and build relationships with local Regulatory Authorities.- Lead the implementation of the Country Quality system, ensuring safe, efficient, quality products and services across country organizations.- Develop and maintain a comprehensive understanding of EU GMP and GDP regulatory requirements.- Manage key quality processes, including the GMP and GDP Training Programme, Product Quality Complaints process, and Internal Audit Programme.- Communicate with the Supply Chain to implement the quality strategy, address compliance issues, and maintain uninterrupted product supply to the market. Ventajas sociales o económicas - Permanent contract directly with the laboratory- Competitive fixed salary + bonus- Health insurance- Stable position and professional career- 50% remote work and 50% office work (Madrid) Qualified Person & Quality Assurance Inizio Engage | (22) ofertas activas Inizio es un partner estratégico dentro del sector Health & Life Sciences. En Inizio Engage, reunimos una serie de capacidades que incluyen advanced analytics, experience design, medical affairs, patient solutions and comercial. Gracias a nuestra combinación única de experiencia en asesoramiento, creación y activación con la tecnología más avanzada, diseñamos y ofrecemos soluciones a medida que inspiran un cambio duradero.Nuestra misión es mejorar la vida de los pacientes a través de la colaboración y el trabajo constante que nuestros equipos realizan con los profesionales de la salud.Actualmente, buscamos profesionales con talento, ganas de aprender y contribuir ¿Estás listo para dar un nuevo paso en tu carrera profesional? ¡Te esperamos! https://inizio.health/ Madrid 28 May. Saber más - - Descripción In Inizio Engage, we are recruiting for a direct and permanent position in a significant laboratory in Madrid, a Qualified Person & Quality Assurance (GDP activities) profile.What would be your main responsibilities?- Ensure local compliance with pharmaceutical regulations and legislation as the Qualified Person (QP), overseeing GDP achievements by the company and subcontractors.- Develop and maintain an effective Pharmaceutical Quality Management System (QMS) to align with EU GMP, GDP, GVP, and Corporate Quality Guidelines.- Collaborate with the Head of Affiliate to optimize departmental efficiency while ensuring compliance with relevant legislation.- Serve as the Responsible Person (RP) and RP (Import), personally fulfilling RP responsibilities.- Provide strategic input for business development, new product introductions, and local commercialization efforts.- Manage the workload, personal development of quality staff, and build relationships with local Regulatory Authorities.- Lead the implementation of the Country Quality system, ensuring safe, efficient, quality products and services across country organizations.- Develop and maintain a comprehensive understanding of EU GMP and GDP regulatory requirements.- Manage key quality processes, including the GMP and GDP Training Programme, Product Quality Complaints process, and Internal Audit Programme.- Communicate with the Supply Chain to implement the quality strategy, address compliance issues, and maintain uninterrupted product supply to the market. Número de vacantes: 1 Modalidad de trabajo: Híbrido (50%) Tipo de contrato: Permanent contract Remuneración anual: Competitive fixed salary + bonus Ventajas sociales o económicas - Permanent contract directly with the laboratory- Competitive fixed salary + bonus- Health insurance- Stable position and professional career- 50% remote work and 50% office work (Madrid) " Requisitos - Pharmacy Degree required, Industry Specialist title is a plus.- Eligible as a Qualified Person with Responsible Person experience.- Extensive pharmaceutical industry expertise, especially in EU Guidelines on GMP and GDP.- Proven track record as a Qualified Auditor, preferable in GDP and GMP, with Spain regulatory inspection management.- Strong background in staff management, multifunctional projects, and organizational skills.- Familiarity with national and international regulations and guidelines.- Demonstrated behavioral competencies: autonomy, pragmatism, effective communication.- Technical competencies include issue resolution, guidance in Quality System & Risk Management, and adaptability in a matrix organization.- Proficient in English (oral and written). Estudios mínimos Licenciado Idiomas Inglés nivel Alto. Experiencia mínima 5 años Disponibilidad para viajar Ninguna #J-18808-Ljbffr
