Role & responsibilities
Computer System Validation (CSV)
Develop, execute, and maintain validation protocols (IQ, OQ, PQ).
Ensure compliance with FDA, EMA, and other regulatory guidelines.
Maintain documentation for audits and inspections.
GxP Compliance
Implement and monitor IT systems in line with GxP requirements.
Support Quality Assurance in system audits and risk assessments.
Ensure data integrity and adherence to ALCOA+ principles.
Pharma Manufacturing IT Systems
Manage ERP, LIMS, MES, and other plant-related applications.
Provide technical support for production and quality operations.
Coordinate with vendors for system upgrades and troubleshooting.
Data Management
Oversee secure handling of electronic records and signatures (21 CFR Part 11).
Ensure backup, recovery, and disaster recovery protocols.
Monitor system performance and implement cybersecurity measures.
Cross-functional Collaboration
Work closely with QA, QC, Production, and Engineering teams.
Support audits, inspections, and regulatory submissions.
Train plant staff on IT compliance and system usage.

📌 It Executive Una (India)
🏢 Stanford Laboratories
📍 India