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Analytical Science

vor 2 Monaten

Kundl, Tirol, Österreich Novartis Vollzeit
About the Role

We are seeking a highly skilled Analytical Science & Technology Manager to join our External Supply Operations team in Austria or Slovenia. As a key member of our Quality organization, you will be responsible for ensuring the execution and maintenance of our quality system, including tools and processes.

Key Responsibilities
  • Support the External Suppliers Qualification process, Tech Transfer assessments, and analytical trouble shooting as needed.
  • Lead, implement, and report to global AS&T the requirements/programs in the assigned ESO QA Network and act as project lead in cross-functional ESO AS&T project teams.
  • Support the definition and implementation of business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply.
  • Support the implementation of Guidelines at the assigned external partners and suppliers, as well as the accountable QAM to define and maintain the ESO Stability Program at CMOs.
  • Lead programs and initiatives to implement changes and to remediate where required.
  • Support the interpretation of stability data, analysis of trends, and provide scientifically sound conclusions for product shelf life assessments, storage conditions, packaging, and transport categories.
  • Assess analytical Change Control records for acceptability and define studies needed to support the changes.
  • Support the QAM to guarantee suspect analytical results investigations are managed in agreement with Sandoz standards and the right CAPA is implemented and ensures Testing Monographs are state-of-the-art.
  • Further support site readiness for Health Authority inspections & participate in audits on request and escalate any issues or instances of instability per the Sandoz escalation policy.