It Executive

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.