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GMP/GDP Compliance Specialist – Warehouse & Distribution Operations (m/f/d)

Merck · Schachen (werthenstein), Switzerland

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Role summary

Merck seeks an experienced GMP/GDP Compliance Specialist for its Lucerne warehouse and distribution operations. The role focuses on quality systems, deviation management, CAPA investigations, SOP development, and regulatory compliance across logistics and material flow processes.

What they're looking for

  • Proven experience in GMP/GDP-regulated environments (pharma, biotech, medical devices, life sciences)
  • Proficiency in deviation reporting, root cause analysis, CAPA management, and change control procedures
  • Strong technical writing skills and SOP/controlled document creation and maintenance experience
  • Fluent in German and English (minimum C1 level, written and spoken)
  • Bachelor's degree in life sciences, engineering, supply chain management, or equivalent professional qualification with extensive industry experience
  • Familiarity with ERP systems, particularly SAP WM/EWM/QM modules

What you'll be doing

  • Lead investigation and documentation of operational deviations, root cause analyses, and CAPA plans per GMP/GDP guidelines
  • Create, review, and maintain SOPs and quality documentation for logistics and material processes
  • Serve as primary quality partner for internal audits and external regulatory inspections; manage audit responses
  • Monitor GMP-critical logistics activities including JIT relabelling, cold chain management, and inventory controls
  • Develop and track quality performance metrics; identify compliance gaps and support sustainable process improvements

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RoleLantern checkedNeeds clarity
Date posted7 days ago
Last source checkToday
Salary listedNeeds clarity
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