Senior Officer, IT User Support
Amneal Pharmaceuticals
JOB 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
- 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.
- 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.
- 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.
- 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.
Support User Access Management and compliance activities for applications such as:
- MES
- E-Logbook
- SCADA/HMI
- Historian
- Manufacturing Execution Systems
QUALIFICATIONS
- Bachelors Degree (BA/BS) B.Tech - Required
- Master Degree (MS/MA) M.Tech - Preferred
- 1 year or more in 1 - 4 Years