Aufgaben

  • Act as the QA Qualification point of contact within project teams for new installations, facility upgrades, or system implementations, ensuring alignment with qualification standards.
  • Align various QA objectives, such as process and cleaning validation requirements, across cross-functional project stakeholders during execution phases.
  • Lead the roll-out of updated qualification approaches and confidently make decisions in complex quality matters when required.
  • Prepare, evaluate, and approve qualification-related documentation, including but not limited to URS, qualification master plans, design/installation/operational/performance qualification reports, and risk assessments like FMEA.
  • Review and authorize technical change controls throughout project stages and operational lifecycle, ensuring continued qualification compliance of systems, utilities, and equipment.
  • Serve as a subject matter expert for qualification topics during audits by clients and health authorities.
  • Manage quality deviations, ensure thorough investigations, and oversee timely closure of CAPAs and effectiveness evaluations.

Qualifikationen

  • University degree in a scientific or technical discipline such as Biotechnology, Chemistry, or Engineering.
  • Proven experience with qualification activities in the pharmaceutical sector.
  • Familiarity with cGMP guidelines and regulatory expectations is advantageous.
  • Solid understanding of manufacturing and technical operations.
  • Competence in identifying quality issues within project execution and taking corrective action.
  • Proficiency in both English and German is essential.