Responsibilities:
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:
Solid 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.