QA Specialist QMS Support

Job Description

Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Key Responsibilities: 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.