Technical Support - Application
Division
Information Technology
Department
Sub Department 1
Job Purpose
Maintain and administer User Access Management for GXP applications at the site, ensuring compliance with policies and procedures, supporting IT readiness for audits, and enabling business operations without disruption.
Key Accountabilities (1/6)
Provide timely support to meet business system access requirements at locations
• Work with Location IT Lead to support User Access Management for GXP, non-GXP applications
• Creation, Modification, deactivation and activation / unlocking of User Accounts
• Creation, updating the privilege groups and assigning the privileges to groups
• Be part of QA review of user management policy and Audit trail review as per defined SOP’s with QA team
Key Accountabilities (2/6)
Provide IT Admin Support for effective service delivery to business functions
• Ensuring that the Server data backup is performed as per the schedule and verifying the same
• Time synchronization activity related to instrument and Software
• Creation of New year data base for all the software and mounting of the same for site laboratories
• Archival and Deletion of Audit trail in Tiamo Software, MCP etc
• Coordinate with vendor in resolving the software issues and providing a resolution
Key Accountabilities (3/6)
Implement and adhere to the computer system validation process for GXP Systems at locations
• Ensure required documentation and validation of IT systems as per procedures and regulatory requirements
• Review and commenting on User admin activity related SOPs for various GXP applications
• Ensure systems are complied with required defined security and desktop policies
• Ensure IT compliance & support during internal, customer and regulatory audits
Key Accountabilities (4/6)
Key Accountabilities (5/6)
Key Accountabilities (6/6)
Major Challenges
Implementing and harmonising a new system, process or application across location units
Key Interactions (1/2)
Internal
All location function users and internal IT team
Key Interactions (2/2)
External
GXP System vendors for support and services• External / Internal auditors as and when required
Dimensions (1/2)
• Ensuring 100% IT readiness for all regulatory, Customer and IT Audits
• Ensuring 100% compliance to Data Backup, Verification & Restoration for in scope GXP systems
• Maintain Strict compliance to User Access Management process for in scope GXP systems
Dimensions (2/2)
Key Decisions (1/2)
Decisions
Maintenance for planned and unplanned system downtime
Key Decisions (2/2)
Recommendations
Provide technology proposals and vendors
Education Qualification
University graduate, preferably in Computer Science or related discipline.
Relevant Work Experience
4-6 years of relevant experience in technical support for applications, with a focus on compliance and regulatory environments.