- Develop validation protocols and test scripts to meet regulatory standards.
- Execute documented tests to validate instruments in the GLP workplace.
- Prepare IT SOPs to implement standard procedures for IT operations.
- Manage Quality Control Servers, Backup Devices, and Backup
- Monitoring for IT QC administration.
- Coordinate with service providers for chromatography device support, installation, and maintenance.
- Oversee computer system validation for chromatography data systems.
- Perform IQ and OQ verification for chromatography data systems.
- Initiate change control for chromatography and non- chromatography systems.
- Ensure compliance and update group policies on network security for various instruments such as chromeleon, shimadzu lab solutions, FITR, UV, TOC, aglient, GC shimadzu, and stabilitychambers thermo lab.
- Manage non-chromatography users and user roles based on Privilege Matrix (SOP).
- Monitor daily backups and schedule data restoration to prevent data loss and corruption.
Required Skills:
- Strong understanding of instrument validation protocols and test script creation.
- Proficiency in implementing IT SOPs and standard procedures.
- Knowledge of chromatography data systems and computer system validation.
- Excellent coordination and communication skills for working with service providers.
- Detail-oriented approach to managing compliance and data security.