AS&T Hub Expert

321015BR
Jun 11, 2021
Turkey

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
NTO QUALITY
Turkey
İstanbul
Tam Zamanlı
Daimi
Hayır
321015BR

AS&T Hub Expert

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