Analytical Science

Vor 4 Tagen

Kundl, Tirol, Österreich Novartis Vollzeit
Job Title: AS&T Manager – ESO Biosimilars

Sandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines.

We are seeking a highly skilled AS&T Manager to join our External Supply Operations ESO Biosimilars team in Kundl, Austria or Slovenia Site.

Your Key Responsibilities:
  • Execute and maintain the quality system for External Supplier Operations (ESO) Analytical Science & Technology (AS&T), including tools and processes.
  • Support the Quality Assurance Manager (QAM) in solving analytical and stability questions for assigned suppliers in the scope of the ESO Biosimilars Quality organization.
  • 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 defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply.
  • Implement Guidelines at assigned external partners and suppliers, and support the accountable QAM to define and maintain the ESO Stability Program at CMOs.
  • Lead programs and initiatives to implement changes and 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 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.
  • Support site readiness for Health Authority inspections and participate in audits on request, escalating any issues or instances of instability per the Sandoz escalation policy.

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