Provides MES configuration and support services to meet end-user needs.
Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state.
Coordinates the needs of functional departments and establishes priorities for MES requirements gathering, system design and implementation.
Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle, including User Requirement Specifications, Functionality Specifications, and Configuration Specifications.
Reviews company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess impact to MES related IT infrastructure and processes.
Works with Validation and Quality Assurance departments to ensure MES is implemented following development life cycle approach.
Provides end-user support for the MES including troubleshooting problems at the application server level.
Performs User Management and system administration functions in MES.
Recommends and installs systems updates, patches, services packs, and hot fixes.
Monitors applications for readiness, availability, and performance trend analysis.
Maintains disaster recovery environment and ensure periodic testing is performed.
Logs application support incidents and prepares appropriate resolution plans.
Third level Degree essential
Must have industry experience working with a GMP environment