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
Job Title: Quality Assurance Development Associate
- 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 documentation -Supports Compliance review of projects and inspection readiness and management
Competence / Expertise and Experience
- Functional Breadth
- Risk Management
- Quality decision making
- Knowledge of compliance requirement for all internal and external regulations
- Knowledge of TQM and related industry GxP standards and processes Quality Standards
- Supporting Quality activities / issues Process management
- Technical knowledge
- 3-4 years relevant experience
- Clinical Research Phases Knowledge of GMP
- Knowledge of CAPA Good Documentation Practice
- Inspection Preparedness
Bachelors Degree in Life Sciences or related field