NuGenesis Consultant

Job Description

Role: NuGenesis Consultant

Required Technical Skill Set: NuGenesis

Desired Experience Range: 6+ years

Location of Requirement: PAN India preferably Noida

Must-Have**

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.

Responsibility of / Expectations from the Role

• 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 environment.
• 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.