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10100055 Fresenius Kabi Deutschland GmbH

Process Architect Quality Management / Complaint Management(m/w/x)

Bad Homburg vor der Höhe
Full-timeOn-siteExperienced
AI/ML

In this role, you will shape quality management processes, focusing on complaint and event management while collaborating with IT and business teams. Your work will drive digital transformation and ensure compliance across global manufacturing sites.

Requirements

  • University degree in Life Sciences, Quality Management, Engineering, or related field
  • Extensive experience in quality management process design
  • Proven track record in implementing modern quality management platforms
  • Experience integrating Artificial Intelligence solutions into quality management processes
  • Demonstrated expertise in defining master data and managing digital transformation initiatives
  • Strong understanding of quality management principles and regulatory requirements
  • Proficiency in using quality management software platforms and advanced data analytics tools
  • Experience in creating detailed process documentation
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and ability to collaborate effectively
  • Exceptional analytical skills with keen attention to detail
  • Proven ability to identify issues and implement innovative solutions
  • Demonstrated project management expertise
  • Ability to manage multiple priorities in fast-paced environments
  • Proactive, adaptable, and self-motivated
  • Willingness to travel internationally for global implementations

Tasks

  • Develop and optimize quality management processes
  • Focus on Quality Complaint Management and Quality Event Management
  • Design and document global process templates for Pharmaceutical and MedTech operations
  • Define critical process parameters and master data elements
  • Support the implementation of modern Quality Management Platforms
  • Integrate Artificial Intelligence solutions for enhanced efficiency
  • Collaborate with IT and business stakeholders for seamless system integration
  • Work with global manufacturing sites to deploy standardized quality processes
  • Collect and analyze feedback for continuous process improvement
  • Ensure compliance with regulatory requirements and industry standards
  • Collaborate with quality assurance teams to develop testing protocols
  • Document process flows, requirements, and test results according to GxP regulations

Work Experience

approx. 1 - 4 years

Education

Bachelor's degree

Languages

EnglishBusiness Fluent

Tools & Technologies

SAP QMIQVIAVeeva
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