Summary

Responsible for implementing and maintaining the ESO AS&T quality system including tools & processes. Responsible for analytical activities in the scope of ESO (e.g. QC activities and stability programs) and providing technical support to suppliers in scope.

About the Role

Major Accountabilities

• Lead, implement and reports on global AS&T requirements/programs in the assigned ESO QA Network. Supports defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply (e.g. data integrity, analytical change management)
• Escalates any analytical issues or instances of instability per the Novartis escalation policy, initiates any market action as required.
• Owns and maintains testing monographs for products in scope of ESO
• Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. This includes, but not only, reviewing registration documents and being in line with pharmacopeia standards.
• Supports the accountable QAM to define and maintain the ESO Stability Program at CMOs, ensures that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation. Leads programs and initiatives to implement changes and remediation as required.
• Interprets stability data, analyses trends, and provides scientifically sound conclusions for product shelf life/re-test assessments, storage conditions and packaging and transport categories. Defines corrective actions to address immerging stability issues together with MS&T.
• Supports and drives analytical trouble shooting
• Owns and/or ensures analytical investigations are managed in agreement with cGxP standards and the right CAPAs are implemented.
• Acts as SPOC for analytical subjects in cross functional ESO AS&T project teams

• Owns tech transfer assessments for analytical method transfers or new analytical methods.

• Owns changes regarding analytics and/or provides the required assessments in regards to analytics during general change control activities. Defines studies/assessments needed to support changes regarding analytics.

• Supports implementation of guidelines at the assigned external partners and suppliers

• Provides the analytical input required for External Suppliers Qualification process

• Supports site readiness for Health Authority inspections & participate in audits on request.

Key Performance Indicators

• Number and severity of AS&T related cGMP issues identified during audits (internal, GCA, HA)
• ESO performance evaluated by the department KQIs
• State of the art of stability program for contractors and testing monographs

Specific Professional Competencies

• Deep knowledge of GMP and regulatory requirements (FDA, EU, MHRA, etc.)
• Good communication and interpersonal skills
• Stakeholder (internal and external) management

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