Description
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.
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.
GxP Compliance
Ensure compliance with:
21 CFR Part 11
EU GMP Annex 11
ALCOA+

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