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
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- 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
