Description:

Manage User Access Management (UAM) activities for Production Shop Floor GxP
applications, including user provisioning, modification, deactivation, periodic
access reviews, and compliance with regulatory requirements. Handle IT-related
QMS activities such as Deviation, CAPA, Change Control, Incident Management, and
support regulatory audits while ensuring GMP, Data Integrity, and 21 CFR Part 11
compliance.

Essential Functions:
Provide first-line technical support for hardware and software issues
Diagnose problems through user interaction and system checks
Perform troubleshooting and fault rectification
Escalate unresolved issues as per defined protocols
Ensure timely resolution of user queries and complaints
Document incidents, actions taken, and resolutions
Support basic system access and device setup
Adhere to IT policies, security, and service standards

KEY RESPONSIBILITIES
USER ACCESS MANAGEMENT (UAM)
Manage end-to-end User Access Management (UAM) activities for GxP
applications.
Create, modify, disable,



and delete user accounts based on approved requests.
Perform periodic User Access Reviews (UAR) and Privileged Access Reviews.
Maintain User Access Matrix and Role-Based Access Control (RBAC).
Ensure Segregation of Duties (SoD) compliance.
Coordinate with Application Owners, QA, HR, and Functional Teams for access
approvals.
Maintain audit-ready documentation for all access-related activities.
Ensure timely deactivation of user accounts during employee separation or
role changes.

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QUALITY MANAGEMENT SYSTEM (QMS)
Handle IT-related QMS activities including:
Deviation
CAPA
Change Control
Incident Management
Risk Assessment
Corrective and Preventive Actions
Prepare and review investigation reports.
Coordinate with QA for closure of QMS records.
Ensure timely completion of compliance activities.

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📌 Senior Officer, It User Support Ahmedabad
🏢 Amneal India
📍 Ahmedabad