Beschreibung

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.

Anforderungen

• •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

Aufgaben

• •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 & Technologien

Benefits