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ishaan asthana

@ishaanasthana

Message

Validation Analyst combining CSV for PV software with SQL/PL-SQL expertise.

India

Message

What I'm looking for

I’m looking to join a CSV/IT QA team where I can author and execute IQ/OQ/PQ, manage deviations and traceability, and use SQL/PL-SQL to strengthen audit-ready pharmacovigilance system validation.

I’m a detail-oriented Computer System Validation (CSV) and IT Quality Analyst focused on GxP-compliant validation lifecycle management for pharmacovigilance software platforms. At Vitrana, I author end-to-end IQ/OQ/PQ scripts for Oracle Argus Safety and Oracle Analytics deployments, ensuring alignment with GAMP5 principles, 21 CFR Part 11, and GxP guidelines.

I maintain Requirements Traceability Matrix (RTM) coverage, execute manual validation cycles, and manage deviations and CAPA actions through coordination with QA and development teams. I also configure rule-based system settings and workflows post-validation, support change control impact assessments, and write SOPs and QMS documentation to stay inspection-ready.

Experience

Work history, roles, and key accomplishments

Current

Validation Analyst & Associate

Current

Vitrana

Jan 2025 - Present (1 year 6 months)

Authored and executed IQ/OQ/PQ validation scripts for Oracle Argus Safety and Oracle Analytics deployments, maintaining audit-ready validation documentation aligned to GxP, 21 CFR Part 11, and GAMP5. Managed RTM, deviations/CAPA, change control impact assessments, and configured compliant post-validation production system workflows.

Oracle Argus Safety Oracle Analytics GxP Deviation Management CAPA Change Control Validation Summary Reports Pl SQL SQL Functional Testing Regression Testing Regulatory Compliance

Data Analyst Intern

Leverage

Jan 2024 - Present (2 years 6 months)

Validated structured content during a CMS migration to Next.js 14 and Strapi, ensuring data integrity and consistency across large volumes of dynamic entries. Reconciled migrated records with SQL and tested dynamic content rendering accuracy, including lead-source UTM tracking logic.

SQL Data Validation Data Reconciliation Next.js Strapi CMS migration Dynamic Content Data Integrity