SHRISTI SAXENA

Project: Cloud Migration across AWS environments

• Tech Stack: Databricks ETL Pipelines, AWS, Data Warehousing, CDOCS, Python, PySpark, SQL, GxP
• Migrated clinical modeling workloads from Client-hosted infrastructure to Vendor-hosted cloud
• Reducing maintenance overhead and improving scalability.
• Defined ETL pipelines for ingestion and transformation of clinical trial data under GxP standards
• Created HLDs and data flow diagrams to support regulatory audit documentation
• Acted as the primary liaison with QA and Validation teams to ensure compliance and CAPA coverage

Project: Data Engineering & Compliance

• Tech Stack: Databricks ETL Pipelines, PySpark, AWS, Python, CDOCS, Data Security
• Supported ongoing enhancements and KTLO tasks for biomarker data pipeline.
• Led delivery for Security tool - Privacera Sunset release.
• Designed scalable data ingestion workflows for high-throughput genomic data
• Proposed automation enhancements that improved validation turnaround time by 30%

Validation Leadership across GxP Projects

• Led test case creation, execution, and deviation handling for validated systems
• Ensured audit readiness by managing controlled documentation in CDOCS
• Coordinated functional testing with QA for validated systems hosted on AWS

Project: Clinical Data Automation Platform

• Tech Stack: PySpark, Kedro ETL Pipeline, PostgreSQL, AWS, Dash
• Built ETL pipelines for clinical data harmonization, enabling analytics and visualization layers for global stakeholders.
• Automated ingestion of biomarkers, and patient datasets across multiple studies building reusable data quality modules with custom DQM checks
• Developed interactive dashboards using Dash and RShiny for client-facing reports

Project: Data Reporting Rationalization:

• Tech Stack: SQL, Python, JIRA, HP ALM, Data Modelling
• Audited and rationalized 1̃00+ legacy reports used across business units to identify opportunities for consolidation.
• Partnered with business leads to defining metrics and eliminating redundant reports

GxP Validation & Testing Initiatives

• Developed and executed IQ/OQ/PQ protocols and traceability matrixes aligned to FDA 21 CFR Part 11, and conducted UAT with stakeholders