Job Description
**mandatory
SN Required Information Details
1 Role** NuGenesis Consultant
2 Required Technical Skill Set** NuGenesis
4 Desired Experience Range** 6+ years
5 Location of Requirement PAN India preferably Noida

Desired Competencies (Technical/Behavioral Competency)
Must-Have**
(Ideally it should not be more than 3-5) Waters NuGenesis application support, NuGenesis SDMS, laboratory informatics support, L2/L3 AMS support,, GxP, 21 CFR Part 11, Pharma domain experience,
Good-to-Have Waters NuGenesis , LIMS (Labvantage), Pharma domain, GxP, GMP, 21 CFR Part 11, Data Integrity, Audit Trail, CSV, Validation.

SN Responsibility of / Expectations from the Role
1 Provide day-to-day AMS support for Waters NuGenesis applications across multiple pharmaceutical manufacturing, QC, R&D;, and laboratory sites.
Handle L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL processes.
Support NuGenesis SDMS, LMS, and ELN administration activities including user access, roles, privileges, electronic signature setup, audit trail support, workflow configuration, and routine application maintenance.
Support scientific data capture, archival, retrieval, metadata indexing, print capture, file capture templates, data retention, and laboratory data lifecycle processes within NuGenesis.
Coordinate with site laboratory teams, business users, infrastructure teams, database teams, network teams, vendors, and global application owners for issue resolution and operational continuity.
Support NuGenesis integrations and interfaces with laboratory instruments, Empower CDS, ERP, Microsoft Office, file servers, and other enterprise systems as applicable to site operations.
Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volume.
Execute and support change management activities including impact assessment,



change documentation, testing coordination, deployment support, and post-implementation validation in a GxP workplace.
Ensure compliance with GxP, GMP, GLP, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, audit trail, access control, electronic records, electronic signatures, and computer system validation requirements.
Support periodic reviews, access recertification, system health checks, SOP adherence, deviation/CAPA support, and audit readiness activities related to NuGenesis.
Assist with NuGenesis upgrades, patches, hotfixes, configuration changes, validation testing, regression testing, and documentation updates across global or regional sites.
Create and maintain support documentation including knowledge articles, SOPs, troubleshooting guides, runbooks, configuration records, test evidence, and operational handover documents.
Monitor application availability, ticket trends, SLA performance, recurring issues, user pain points, and service improvement opportunities for multi-site AMS operations.
Identify process improvement opportunities across incident handling, ticket triage, recurring issue management, knowledge management, access request handling, and multi-site support operations to improve efficiency and service quality.
Explore and propose opportunities to use automation and Gen AI for support activities such as ticket summarization, knowledge article creation, SOP/runbook drafting, trend analysis, root cause insights, self-service enablement, and faster incident resolution, while ensuring data privacy, compliance, and validation requirements are met.
Participate in daily/weekly service reviews, status reporting, incident bridges, major incident support, and stakeholder communications for business-critical issues.
Support onboarding of new sites, transition activities, hypercare support, knowledge transfer, and standardization of NuGenesis support processes across sites.
Work in shift-based or extended-hours support model as required to support global pharma operations and ensure timely response to critical laboratory system issues.

📌 102379-1-Nugenesis Support (India)
🏢 Objectwin Technology India
📍 India