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)
🏢 Stanford Laboratories
📍 Una