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DEG FedEx Express Deutschland GmbH
5d ago

Senior Healthcare Quality Engineer(m/w/x)

Köln
Full-timeWith Home OfficeSenior

Description

You will ensure the integrity of global pharmaceutical logistics by managing cold chain compliance, conducting rigorous validations, and leading quality audits to meet international regulatory standards.

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Requirements

  • •Degree in Engineering, Pharmaceutical Sciences, or Logistics
  • •Experience in pharmaceutical cold chain or GDP
  • •Experience with CEIV Pharma certification and audits
  • •Knowledge of WHO PQS standards
  • •Technical understanding of temperature mapping and validation
  • •Skill in quality tools like CAPA/FMEA
  • •Excellent written and verbal communication skills
  • •Fluent English and German language skills
  • •GDP, ISO 9001, or ASQ certifications
  • •Experience with global health or biologics
  • •Familiarity with QMS and IoT monitoring
  • •Proficiency in project management and analysis tools

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •Maintain the QMS for pharmaceutical transport
  • •Validate cold chain lanes and storage areas
  • •Analyze temperature excursions and deviations
  • •Implement root cause analysis and CAPAs
  • •Prepare validation protocols and mapping records
  • •Manage CEIV Pharma and IATA compliance audits
  • •Conduct vendor and carrier qualification audits
  • •Apply WHO PQS guidelines to supply chains
  • •Implement risk-based controls for cold chain operations
  • •Generate SOPs and controlled documentation
  • •Train staff on temperature-sensitive handling
  • •Optimize processes for pharmaceutical clients
  • •Perform process mapping and time studies
  • •Support customer onboarding and RFQ responses
  • •Define KPIs and develop operational SOPs
  • •Lead technical initiatives during customer audits

Tools & Technologies

CAPARCA5 Whys8DFMEAQMS platformsData loggersIoT-enabled temperature monitoring systemsThermal packaging validationMicrosoft ProjectSmartsheetAsanaMonday.comJiraGantt ChartsRACI MatricesPareto AnalysisDMAIC

Languages

English – Business Fluent

German – Business Fluent

Benefits

Competitive Pay

  • •Attractive compensation package

Additional Allowances

  • •Tuition Assistance Program

Flexible Working

  • •Hybrid working policy

Mental Health Support

  • •Employee Assistance Program

Corporate Discounts

  • •Employee reduced-rate shipping

Career Advancement

  • •Growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DEG FedEx Express Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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