Role & responsibilities

Support Lead GxP Systems - LIMS Job Description

SubTSR Support Lead - LIMS

Position Title

Support Lead – GxP Systems - LIMS

Experience

4–8 Years

Industry

Pharmaceuticals / Medical Devices / Clinical Research

Location

India / Hybrid / Remote

Job Summary

We are seeking a skilled Support Lead with experience supporting regulated GxP systems within pharmaceutical, medical device, and clinical research environments.

The candidate will be responsible for providing application and operational support for critical regulated platforms including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and related GxP applications.

The ideal candidate should possess robust troubleshooting skills, understanding of regulated environments, incident management expertise, and the ability to support business-critical applications while maintaining compliance and system availability.

Key Responsibilities
- Provide Level 2 / Level 3 support for regulated GxP applications and functional knowledge in LIMS




• Support and maintain systems such as LabVantage LIMS, DMS, Planisware, Empower. CDS systems, laboratory applications, manufacturing systems, and quality systems.
• Monitor application health, system performance, and service availability.
• Investigate and resolve application incidents, defects, and user-reported issues.
• Perform root cause analysis and implement corrective actions.
• Manage service requests, tickets, and issue tracking through ITSM tools.
• Support system upgrades, patches, releases, and configuration changes.
• Coordinate with vendors and internal technical teams for issue resolution.
• Ensure compliance with GxP, 21 CFR Part 11, Data Integrity requirements, and Change Management procedures.
• Support audit and inspection readiness activities.
• Prepare and maintain support documentation, SOPs, and knowledge articles.
• Participate in on-call or production support activities when required.

Required

📌 Walk-in || LIMS Support Lead (Hyderabad)
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