- Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers.
- Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers.
QA Manager - Kundl, Österreich - Novartis
Beschreibung
QA Manager (d/f/m) ESO, Kundl, Tyrol, Austria
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' Sandoz
This position ensures all aspects of manufacturing, testing, release and distribution for bio-logics and/or sterile pharmaceutical products at external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.
Your responsibilities include, but are not limited to:
Supplier qualification:
Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs.
Routine monitoring:
Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews.
Incident management:
Manages all quality issues (complaints, deviations, OOX).
Change controls:
Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure.