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

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: