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.