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+ Principles
- Data Integrity Guidelines

- Support implementation of GMP and Data Integrity requirements.
- Ensure documentation complies with regulatory expectations.

4. Audit Support

- Support Regulatory Audits such as:
- USFDA
- MHRA
- EU GMP
- WHO
- Internal Audits
- Customer Audits

- Prepare audit documents and evidence.
- Respond to audit observations.
- Track audit CAPAs until closure.

5. Production & Laboratory Application Support

Support User Access Management and compliance activities for applications such as:

- MES
- E-Logbook
- SCADA/HMI
- Historian
- Manufacturing Execution Systems

Education:

- Bachelors Degree (BA/BS) B.Tech - Required

- Master Degree (MS/MA) M.Tech - Preferred

Experience:

- 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses:

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