Aufgaben

  • Review and assess electronic and/or manufacturing protocols to ensure alignment with GMP standards. Assist in the development or revision of manufacturing protocols to meet GMP manufacturing requirements
  • Ensure compliance with both internal and external GMP standards and regulatory guidelines across various projects
  • Engage in cross-departmental investigations to evaluate potential impacts on product quality and define necessary corrective actions
  • Act as the Quality Unit representative in cross-functional teams, making independent decisions related to quality based on regulatory and compliance expertise, while also offering independent quality guidance to project teams
  • Evaluate and approve validation documents

Qualifikationen

  • Degree in Biology, Chemistry, Biotechnology, Life Sciences, or a related discipline, or equivalent experience within the pharmaceutical industry
  • Prior experience in a GMP-regulated pharmaceutical setting is a plus
  • Fluency in English, with a good command of German as a beneficial skill
  • Strong ability to prioritize tasks and manage project timelines in a dynamic environment
  • Excellent communication skills, both verbal and written, with strong interpersonal abilities