- Provide functional and technical support for enterprise and QC-related applications such as ERP, LIMS, QMS, SAP, standalone lab software, and label design software.
- Manage user access, roles, and privileges as per access control SOPs.
- Ensure compliance with 21 CFR Part 11 requirements, including audit trails, electronic signatures, and access controls.
- Conduct periodic user access reviews and maintain documentation.
- Maintain system master data in coordination with user departments.
2. Data Integrity & Security
- Ensure audit trail reviews are performed where applicable.
- Monitor data backup status and restoration testing.
- Ensure antivirus compliance and patch updates.
- Identify and escalate data integrity risks.
3. Incident & CAPA Support
- Log and track application incidents.
- Perform Root Cause Analysis (RCA).
- Support CAPA implementation related to computerized systems.
Preferred Experience: 1 to 3 Years of Relevant Experience