It is imperative that Suvoda staff working with clients, end-users, or the systems that client and end-users interact with understand the clinical trial industry, regulations, Suvoda's software products and processes, and especially the specificities of the unique trial in question before taking any actions they may alter the data of the system in question Manages and facilitates all stages of the Quality Event Management process, including but not limited to, conducting investigations, assessing risk/impact, conducting trend analyses, defining and tracking corrective and preventive actions and associated effectiveness checks Conducts Quality Event Investigations by facilitating and completing root cause analyses: working internally with cross-functional teams to collect and analyze relevant data, utilizing and applying RCA tools (such as flowcharts, fish bone diagrams, 5-Why's analysis, etc.) and ensuring that investigations are conducted in accordance with a GCP-regulated environment
- Applies CAPA disciplines to develop effective corrective and preventive action plans
- Performs quality event trend reviews and facilitates analyses, escalating observations when deemed warranted by QMS process
- Produces client-facing documents/communications, such as Quality Event Investigation Reports; adapting highly technical investigation details for a non-technical audience and communicating investigation progress updates to stakeholders when needed
- Conducts risk assessments and facilitates impact analyses in response to Quality Event Investigations
- Attends weekly Issue Management Team meetings
- Prepares slides for the meetings, takes notes during meetings, and follows up on actions from the meeting, as required
- Prepares and evaluates data pertaining to quality events in preparation of audits and in response to audit findings, working cross functionally with teams to implement process improvements as needed
- Develops and maintains key performance indicators (KPIs) and calculates performance based on data from available sources to support the continuous improvement of the quality management system
- Assists teams to develop new processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledge base articles
- Likewise, performs reviews and revisions of current processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledge base articles to ensure continuous improvement of the Quality Management System
Creates internal reports for stakeholders that provide insight and value regarding product and process performance and/or the status of Quality Event Investigation activities using a combination of Excel and PowerPoint
