- 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 | (35) ofertas activas Madrid 26 Jun. - - 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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