GMP / GDP Auditor (m/f/d).

Job ID: 11425

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Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company operating across international centers specialized in innovative products. For patients with serious and often chronic diseases they provide targeted treatment, which generally enable them to lead almost normal lives.

Responsibilities
  • Planning, implementation and follow-up of self-inspections and external audits (national and international) of suppliers and service providers
  • Quality assurance support of the system for self-inspections, GDP processes and other related processes
  • Ensuring compliance with regulatory and internal quality requirements in their own area of responsibility
  • Risk assessment, analysis and implementation of process improvements with regard to the systems / processes supported
  • Development and implementation of trainings on selected GMP, cGMP and GDP topics
  • Participation and support in the training of auditors and subject matter experts (SMEs)
  • Support during inspections and customer audits
  • Cooperation and management of projects
Requirements
  • Natural scientists specializing in biology, chemistry, medicine or pharmacy or graduates of the respective engineering disciplines
  • Several years of experience in the pharmaceutical GMP/GDP area as well as in the FDA-regulated environment
  • Very good GMP (EU) / cGMP (USA) / GDP knowledge
  • Several years of experience as Lead Auditor in the GMP/GDP area
  • Presentation and training skills
  • Business fluent English skills
  • High willingness to travel (at least 50%)
Region
Mitte