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: 1Modalidad de trabajo: Híbrido (50%)Tipo de contrato: Permanent contractRemuneración 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 mínimosLicenciado**Idiomas**:Inglés nível Alto.- Experiência mínima5 añosDisponibilidad para viajarNinguna
