Summary
About the Role
- Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management.
- Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
- Contributes to an improvement of current processes and/or to an implementation of modified processes.
- Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
- Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentationSupports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- In accordance with departmental objectives such as support of projectswith agreed quality and delivery date -passing of internal and external inspections.
- Maintain sound working relationships with partners and customers -Demonstrated/recognized leader of specific GxP; early external/industry engagement -Basic financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values & behaviors for his/her department
Work Experience:
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.
- Agility.
- Audit Management.
- Business Partnering.
- Change Control.
- Continuous Learning.
- Health Authorities.
- Influencing Skills.
- Knowledge Of Capa.
- Qa (Quality Assurance).
- Quality Management.
- Quality Management Systems (Qms).
- Risk Management.
- Root Cause Analysis (Rca).
- Self Awareness.
- Sop (Standard Operating Procedure).
- Technological Expertise.
- English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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