- Support External Suppliers Qualification process, Tech Transfer assessments for analytical method transfers and analytical trouble shooting as needed
- Lead, implement and reports 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
- Supports defining and implements business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply
- Support 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 to interpret stability data, analyses trends, and provides scientifically sound conclusions for product shelf life assessments, storage conditions, packaging and transport categories
- Asses analytical Change Control records for acceptability and define studies needed to support the 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 stateoftheart
- 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
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AS&T Manager – ESO Biosimilars - Kundl, Österreich - Novartis
Beschreibung
Analytical Science & Technology Manager (AS&T)– External Supply Operations ESO Biosimilars (d/f/m), Kundl, Austria or Slovenia Site
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now 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 us, the Sandoz associates.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' SandozYour key responsibilities:
Responsibility for execution and maintenance of quality system for External Supplier Operations (ESO) Analytical Science & Technology (AS&T), including tools and processes.
Support function for the QAM (Quality Assurance Manager) for solving analytical and stability questions for assigned suppliers in the scope of the ESO Biosimilars Quality organization in accordance with regulation, internal guidelines, GMP and business goals.
Your responsibilities include, but are not limited to:
