AS&T Manager – ESO Biosimilars

vor 1 Monat

Kundl, Tirol, Österreich Novartis Vollzeit
Transformative Period for Sandoz

Sandoz is undergoing an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for its associates.

Your Key Responsibilities

As a key member of the ESO Biosimilars Quality organization, you will be responsible for the execution and maintenance of the quality system for External Supplier Operations (ESO) Analytical Science & Technology (AS&T), including tools and processes.

You will support the Quality Assurance Manager (QAM) in solving analytical and stability questions for assigned suppliers in accordance with regulation, internal guidelines, GMP, and business goals.

Key Tasks
  • Support External Suppliers Qualification process, Tech Transfer assessments for analytical method transfers, 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 defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply.
  • Support the implementation of guidelines at 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 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 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 and escalate any issues or instances of instability per the Sandoz escalation policy.

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