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E10 France3 days ago

Quality Assurance Supervisor (m/f/d)

On-site · Hamburg, Hamburg, Germany

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Quality Assurance Supervisor responsible for oversight and implementation of Marken QMS, SOPs, and processes across storage, distribution, and kit production as applicable; ensure compliance with GMP, GDP, GSP, ISO 13485, and ISO 9001; lead QA activities including internal audits, client/regulatory audits, CAPA, vendor qualification, change control, trending/KPI reporting, and training needs; provide liaison with clients and cross-functional teams to implement quality improvements, maintain regulatory compliance, and lead QA initiatives and leadership of QA staff.

Required Qualifications

  • 5+ years of experience in a Quality Assurance role within a GMP/GDP/GSP regulated position
  • Bachelor of Science or equivalent university degree
  • Comprehensive knowledge of GMP, GSP, GDP; strong understanding of local regulations
  • Experience with Quality Management Systems (QMS) and CAPA processes
  • Strong written and oral communication skills in English
  • Proficiency with Microsoft Office
  • Ability to travel as required by Line Manager
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E10 France

Quality Assurance Supervisor (m/f/d)

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