AS&T Hub Expert

Jun 11, 2021

Job Description

· Lead, implement and reports on global AS&T requirements/programs in the assigned Network. · Support defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within IM/ Small Molecules Platform (e.g, data integrity, change management, maintenance of testing monographs)
· Support analytical trouble shooting as needed
· Act as project lead in cross functional AS&T project teams
· Support Implementation of Guidelines at the assigned external partners
· Lead programs and initiatives to implement changes and to remediate where required
· Support to interpret stability data, analyze trends, and provide scientifically sound conclusions for product shelf life assessments, storage conditions, packaging and transport categories.
· Support Tech Transfer assessments for analytical method transfers.
· Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
· Support QAM to guarantee suspect analytical results investigations are managed in agreement with Novartis standards and the right CAPA is implemented.
· Support QAM to ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation.
· Support site readiness for Health Authority inspections & participate in audits on request.
· Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required.

Minimum Requirements

Novartis Technical Operations
Tam Zamanlı

AS&T Hub Expert

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