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QUALITY AUDITOR GMP

Descripción de la oferta de empleo

Global Quality AuditorReports to: Global Head of QualityThe company:The organisation, a global pharmaceutical company headquartered in Spain, operates worldwide in scientific research, manufacturing, and marketing of pharmaceutical products for human health. It comprises three divisions: Industrial, Branded, and Biotech, with 6000+ professionals in 40+ countries, 15+ facilities, 10+ R&D centers, and 10 commercial offices. They serve 1,150 customers in 96 countries, focusing on innovation, sustainability, and affordable access to quality medicines.Role Overview:The Global Quality Auditor reports to the Global Quality Audit Regional Team Leader. Their main responsibility is to conduct GxP Quality audits on a global scale.Responsibilities:Supporting the development of a global risk-based audit strategy.Planning, conducting, and documenting GMP audits worldwide in line with quality procedures and regulations.Handling complex audits, including sterile API, aseptic DP, and combination products, by assessing risks effectively.Providing technical guidance, mentoring, and training on audit activities.Offering regulatory advice for remediation and filing recommendations.Preparing audit reports, ensuring timely communication with audit sites.Escalating critical findings and supporting follow-up actions.Reviewing responses to audit findings and ensuring compliance with procedures.Acting as a GMP compliance consultant for various projects.Monitoring qualification activities and staying updated on regulations.Identifying best practices and contributing to auditor development.Reporting relevant metrics as requested.Qualifications:Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.Excellent English communication skills, and Spanish proficiency is a plus.Minimum of 4 years' experience in GMP-regulated organizations.Strong understanding of EU and FDA regulations for pharmaceutical R&D, manufacturing, and distribution.Objectivity and consistency in audits, effective communication skills, personal integrity.Email applicants please forward to; jake.tookey@discoverinternational.com. With a copy of your CV and your availability for an initial screening call.
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Detalles de la oferta

Empresa
  • Discover International
Localidad
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 05/09/2024
Fecha de expiración
  • 04/12/2024
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