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)
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*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