ive / IT

Role & responsibilities

1. CSV (Computer System Validation)

• Develop and execute validation plans, protocols, and reports for computerized systems, including those used in manufacturing, quality control, and distribution.
• Ensure compliance with regulatory requirements, such as GMP, 21 CFR Part 11, and EU Annex 11.
• Collaborate with cross-functional teams to identify and mitigate risks associated with computerized systems.
• Develop, review, and revise SOPs, policies, and procedures related to IT Department.

2. QMS

• Investigate, document, and track IT-related deviations, including system failures, data integrity issues, and procedural non-compliances.
• Collaborate with cross-functional teams to identify root causes, implement corrective actions, and prevent future deviations.
• Ensure deviations are properly documented, approved, and closed in accordance with SOPs and regulatory requirements.
• Manage the change control process for IT systems, including assessment, documentation, approval, and implementation of changes.
• Ensure changes are properly assessed for risk and impact on product quality, safety, and efficacy.
• Collaborate with IT teams to implement changes and verify their effectiveness.
• Identify, document, and track CAPA opportunities related to IT systems and processes.
• Collaborate with cross-functional teams to develop and implement CAPA plans, including root cause analysis and corrective actions.
• Verify the effectiveness of CAPA initiatives and ensure they are properly documented and closed.

3. System Support

• Provide technical support for various systems used in QC & Manufacturing facilities.
• Collaborate with IT teams to ensure system uptime, performance, and security.
• Develop and maintain system documentation, including schedules, logbooks, etc.
• Plan, test, and implement system upgrades, ensuring minimal disruption to business operations.
• Oversee and perform data backup tasks, monitor job success, and address failures promptly.
• Regularly test backup and recovery procedures to confirm their reliability and effectiveness.
• Support regulatory inspection and quality audits, inspection readiness and qualification of service providers and preparation of audit responses with respect to computerized systems compliance.