Major accountabilities:

• 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)

Key performance indicators:

• 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

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.

Skills:

• 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.

Languages :

• English.