ESO AS&T Expert

• Responsible for implementing and maintaining the ESO AS&T quality system incl tools & processes. Responsible for providing technical support and problem solving on QC and sta-bility aspects of the ESO QA Network assigned. Supportive function to QAMs to solve analyti-cal and stability issues at the assigned suppliers/CMOs.
• 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
• Supports the accountable QAM to define and maintain the ESO Stability Program at CMOs and ensure that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation. 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. Provide corrective actions to address immerging stability issues.
• 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. Defines programs and initiatives to be implemented by the QAM to change and upgrade Testing Monographs where required
• 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

• 5-8 years experience in the pharmaceutical industry
• Mind. 5 years experiences in QC, method develop-ment, validation or stability testing
• Thorough knowledge of cGMP requirements.
• Thorough knowledge of cGMP, ICH guidelines, regula-tory requirements & risk management. .
• Good leadership skills and experiences in leading project teams
• Strong track record in project management
• Higher university degree (e.g. Ph.D.) in Biochemistry, Chemistry, or another related science
• Fluent in speaking / writing in English

Division

Business Unit

Country

Work Location

C

ompany/Legal Entity

N

F

unctional Area

Q

J

ob Type

F

E

mployment Type

R

S

hift Work

N