Job Description Summary
Support functions in the Americas region on the market and distribution batch release process through review and preparation of relevant documents, and when applicable final disposition decision, in accordance to global and local regulations and processes.
Job Description
Major Acountabilities
• Review of relevant GxP documentation that support product release and packaging material release.
• Where the activity has been delegated, perform the final disposition decision on finished product and packaging material.
• Perform pre-release checks and activities that make the preparation process more agile.
• Perform local operations that support product release to the market and commercialization, such as, but not limited to: review of temperature data loggers, exception management (temperature excursions), master data management, product returns, customer clarification letters, etc.
• Workflow improvement through identification issues and reporting to the business partner.
• Hold and manage key accounts in workflow applications to ensure appropriate execution of service deliverables.
• Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions if required.
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
• Regularly communicate with partners to collect feedbacks on support services, report deliverable and acquire process knowledge.
• Support implementing process quality improvement projects within the organization.
• Process requiring management intervention to resolve (partner escalation)
Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence