• Monitor Quality Performance and trends Quality Events of the site
  • Serves as the Trackwise Administrator and Subject Matter Expert for the site
  • Work with the Compliance Lead and other Department Managers to ensure timely closure of all quality events
  • Analyze and present Quality related metrics reports, data and Key Performance Indicators (KPIs)
  • Investigate non-product related non-conformance with the required personnel / department on site to develop CAPA and effectiveness checks
  • Participate in the Quality Risk Management Program and Assessment, develop Quality Risk Assessment Reports
  • Work with the Compliance Lead to evaluate new company Global Quality Standards, and implement
  • When required, participate in the internal audit programs as internal auditor
  • Maintains the GMP documents in the Documentum in a GMP compliant manner
  • Communicate potential quality risks / issues based on trends / observations to the management team
  • Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to company Global Quality Standards


  • Studies in pharmaceutical, biopharmaceutical or relevant field
  • Experience in a GMP environment within the pharmaceutical/biopharmaceutical business environment
  • Collaboration and interpersonal skills with excellent skills at building and maintaining constructive and effective relationships with team members
  • Strong ability to assess and make informed decisions
  • Good verbal and written communication skills in German and English