QA Specialist QMS Support

• Responsible for managing day to day process of Complaint management activities under complaint hub responsibility.
• Identification, reporting and escalation of critical complaint events followed by building the strong collaboration with NCQ sites to ensure customer service, compliance and efficiencies.
• Responsible for performing reconciliations with stakeholders, e.g. NPS and MedInfo and responding client with the final outcome of complaints.
• Responsible for preparing Quality trends, evaluate and support team for driving Continuous improvement for processes and product quality performance.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all GxP related activities and that compliance with cGMP is maintained through training and internal audits.
• 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.
• Proficiency in speaking and writing Japanese is a plus and will be considered an added advantage.
• 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 documentation -Supports 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)

Commitment to Diversity & Inclusion: :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Essential Requirements:

• Quality standards are understood, designed into work activity, and achieved.
• In accordance with departmental objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections

Desirable Requirements:

Work Experience:

• Functional Breadth.