Aufgaben

  • Establish and maintain the equipment qualification system, ensuring compliance with the Validation Master Plan
  • Manage qualification document lifecycles, including approving SOPs, qualification protocols, and reports
  • Handle compliance-related tasks for equipment qualification in global systems such as LIMS, DMS, SAP, and Trackwise, ensuring adherence to GMP standards
  • Ensure equipment and supplier qualifications meet quality requirements and address audit observations effectively
  • Act as the first point of contact for equipment qualification and maintenance within QA

Qualifikationen

  • Fluency in both spoken and written English