Eso Analytical Science & Tech. Expert

NOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNL. SAN. VE TİC. A.Ş.

•Higher university degree (e.g. Ph.D.) in Biochemistry, Chemistry, or another related science 

•5-8 years experience in the pharmaceutical industry

•Mind. 5 years experiences in QC, method development, validation  or stability testing

•Thorough knowledge of cGMP requirements.

•Thorough 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 
•No military obligation for male candidates

Job Description

 ·      Lead, implement and reports on global AS&T requirements/programs in the assigned ESO QA Network. Supports defining and implements business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply (e.g, data integrity, change management, maintenance of testing monographs)

·       Support analytical trouble shooting as needed

·       Act as project lead in cross functional ESO AS&T project teams

·       Support Implementation of Guidelines at the assigned external partners and suppliers

·       Lead programs and initiatives to implement changes and to remediate where required

·       Supports to interpret stability data, analyzes trends, and provides scientifically sound conclusions for product shelf life assessments, storage conditions, packaging and transport categories.

·       Support External Suppliers Qualification process

·       Support Tech Transfer assessments for analytical method transfers.

·       Support assessments of analytical Change Control records for acceptability.  Define studies needed to support the changes.

·       Supports QAM to guarantee suspect analytical results investigations are managed in agreement with Novartis standards and the right CAPA is implemented.

·       Supports 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.