Qualified Person

hace 2 semanas


Madrid, Madrid, España Pmfarma A tiempo completo

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 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 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
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