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Application Support & Administration
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.
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.
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 Work Location: Goa (In Office)