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QUALITY ASSURANCE MANAGER

Descripción de la oferta de empleo

ROLE: Quality Assurance ManagerREPORTS TO: CEOLOCATION: MadridWORKING MODEL: Site-basedThe CompanyThe client is a Contract Research Organisation (CRO) specialising in pharmaceuticals, providing comprehensive clinical research services nationally and internationally. They are dedicated to supporting the development of research projects and ensuring the highest standards of quality in the pharmaceutical sector.Senior Quality Manager ResponsibilitiesProactively maintain the company quality system and lead Good Clinical Practice (GCP) compliance audits, covering clinical research sites, service providers, and internal systems and processes.Prepare for regulatory agency inspections and actively participate in process improvement initiatives.Build and develop a strong team through coaching and training programs.Develop and maintain quality documents to ensure compliance with applicable Standard Operating Procedures (SOPs).Report and follow up on quality deviations/non-conformities.Manage and participate in regulatory authority inspections and internal/external audits according to the audit plan and SOPs.Prepare audit reports and Corrective and Preventive Action (CAPA) plans.Review Project/Study Plans, Clinical Study Reports, Data Management Plans, Informed Consent Forms, and other research-related documents for accuracy and compliance.Senior Quality Manager RequirementsKnowledge and previous experience in clinical research and CRO environment.Familiarity with GCP and GxP standards.Experience in quality assurance activities and ISO 9001:2015.Bachelor's degree or equivalent experience in Health Sciences.Minimum of 4 years' relevant work experience.Proficiency in English.If you believe you are a suitable candidate for this role, please apply above or email your application to j.casstles-jones@lifesciencepeople.co.ukSuccessful applicants will be contacted within 2-5 working days.
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Detalles de la oferta

Empresa
  • Life Science People
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 06/04/2024
Fecha de expiración
  • 05/07/2024
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