• Ensure cGMP, Valuable Documentation Practices (GDP), Data Integrity, and Data Security Policies are followed.
- Oversee and validate various software in quality control and assurance functions, such as HPLC, IR, UV, and Stability Control systems.
- Manage user accounts, roles, and access rights for quality systems and instruments.
- Backup/archive QC data and ensure its secure storage and restoration.
- Perform administrative tasks for software and hardware systems used in QA/QC departments.
- Coordinate remediation of IT controls in manufacturing systems, focusing on deletion restrictions, user access management, and data backup.
- Conduct cross-functional activities with other departments to ensure alignment with quality standards.
- Train quality control staff on IT system usage and data security practices.
- Monitor and review QMS activities to identify areas for process improvement.
- Lead audits to ensure compliance with regulatory requirements in IT and QMS domains.
- Stay updated with evolving regulatory guidelines in the pharmaceutical sector.