Technical Support - Application Professional

Information Technology

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.

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

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

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

Implementing and harmonising a new system, process or application across location units

Internal

All location function users and internal IT team

External

GXP System vendors for support and services- External / Internal auditors as and when required

- 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

Decisions

Maintenance for planned and unplanned system downtime

Recommendations

Provide technology proposals and vendors

University graduate, preferably in Computer Science or related discipline.

4-6 years of relevant experience in technical support for applications, with a focus on compliance and regulatory environments.