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LOLonza

(Senior) QA Expert Manufacturing Oversight(m/w/x)

Stein (AR)
Full-timeOn-siteExperienced

Quality oversight for sterile medicine manufacturing at global pharma company. GMP and aseptic manufacturing experience required. Relocation assistance, agile career path.

Requirements

  • Solid experience in GMP controlled environment
  • Experience in Quality Assurance
  • Experience in Aseptic manufacturing
  • Sound experience in deviation handling
  • Ideally certified for deviation handling
  • Experience in QA manufacturing oversight preferred
  • Willingness to work in shifts
  • Willingness to be present in manufacturing area
  • Full gowning necessary
  • Preferably daily presence in cleanroom

Tasks

  • Ensure sterile manufacturing runs safely and smoothly
  • Collaborate with production teams to identify and address issues
  • Work in a cleanroom environment daily
  • Establish and maintain quality oversight for sterile manufacturing
  • Advise on GMP and compliance topics
  • Implement and own the GMP Quality System
  • Review and approve quality protocols and reports
  • Oversee GMP-compliant material and personnel flows
  • Lead GMP compliance activities
  • Support and lead quality-related projects
  • Develop QA tools and processes
  • Represent QA during inspections and audits
  • Serve as primary QA contact for compliance issues

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Benefits

Other Benefits

  • Relocation assistance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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