AS&T Hub Expert


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

•Higher university degree (e.g. Ph.D.) in Biochemistry, Chemistry, or another related science
•5-8 years experience in the pharmaceutical industry
•Min. 5 years experiences in QC, method development, validation or stability testing
•Through knowledge of cGMP requirements.
•Through knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.
•Good leadership skills and experiences in leading project teams
•Strong track record in project management
•Fluent in speaking / writing in English
Novartis Technical Operations
Tam Zamanlı
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AS&T Hub Expert

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