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
1. 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.

2. 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.

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

📌 Senior Officer, IT User Support (Ahmedabad)
🏢 Amneal
📍 Ahmedabad