Qualified Person

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 nível Alto. - Experiência mínima 5 años Disponibilidad para viajar Ninguna