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Form of workJob Description
Job Description:
Requirement:
Requirement:
- Gather, analyze and implement analytics requirements from business users to perform CPV analysis.
- Design and implement end to end CPV analysis workflow in TIBCO Statistica (now known as TIBCO Data Science Workbench), to interface with Spotfire (TIBCO Spotfire Platform) for gathering and processing curated inputs for Statistica analysis.
- Develop system to achieve an automated Continued Process Verification (CPV) including the identification and notification of Out of Specification (OOS) and Out of Trend (OOT) results .
- The system will be used to analyze and trend Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), In-Process Control parameters (IPCs).
- Data from this platform will also be used to support investigations.
- Generate visualizations and statistical outputs for control charts, variability charts, process capability charts, runs charts, distribution charts.
- Model data from datasources including but not limited to OSI Pi.
- Create custom data entry and date configuration modules using TIBCO's Statistica Web Data Entry component that will be rendered through TIBCO WebStatistica Server.
- Set up Alarm Checking mechanisms to detect anomalies using TIBCO Statistica's Monitoring and Alerting (MAS) Server to send email notifications with high criticality to individual product SMEs when an Out of Trend (OOT) or Out of Specification (OOS) is detected.
- Create Statistica data outputs to be consumed by TIBCO Spotfire for analytics and reporting.
- Periodically test and deploy solutions to validated environments following standard promotion processes.
- Create and execute IQ (Installation Qualification), OQ (Operational Qualification) and Validation Protocols.
