Location of Requirement: PAN India, preferably in Noida
Must-Have*
*Waters Empower application support, Empower administration, L2/L3 AMS support, chromatographic integration, Data integrity GxP, 21 CFR Part 11, d CSV/validation documentation, Pharma domain experience
, Good-to-Ha
veWaters Empower, LIMS (Labvantage), Pharma domain, GxP, GMP, 21 CFR Part 11, Data Integrity, Audit Trail, CSV, Validatio
n. Responsibili
ty:Provide day-to-day AMS support for Waters Empower applications across multiple pharmaceutical manufacturing, QC, R&D, and laboratory sit
es.Handle L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL process
es.Support Empower administration activities such as user access management, roles/privileges, project creation, instrument/system configuration, audit trail review support, and routine application maintenan
ce.Coordinate with site laboratory teams, business users, infrastructure teams, network teams, database teams, vendors, and global application owners for issue resolution and operational continui
ty.Support Empower client/server components, interfaces, instrument connectivity, instrument integration, acquisition nodes, sample set/sample creation, batch creation and batch Management, processing methods, chromatographic integration, reports, and data review workflows as applicable to site operatio
ns.Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volu
me.Execute and support change management activities including impact assessment, change documentation, testing coordination, deployment support, and post-implementation validation in a GxP environme
nt.Ensure compliance with GxP, 21 CFR Part 11, data integrity, audit trail, access control, and computer system validation requirements while supporting Empower application operatio
ns.Support periodic reviews, access recertification, system health checks, SOP adherence, deviation/CAPA support, and audit readiness activities related to Empow
er.Assist with Empower upgrades, patches, hotfixes, configuration changes, validation testing, regression testing, and documentation updates across global or regional sit
es.Create and maintain support documentation including knowledge articles, SOPs, troubleshooting guides, runbooks, configuration records, and operational handover documen
ts.Monitor application availability, ticket trends, SLA performance, recurring issues, and service improvement opportunities for multi-site AMS operatio
ns.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 quali
ty.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 m
et.Participate in daily/weekly service reviews, status reporting, incident bridges, major incident support, and stakeholder communications for business-critical issu
es.Support onboarding of new sites, transition activities, hypercare support, knowledge transfer, and standardization of Empower support processes across sit
es.Work in shift-based or extended-hours support model as required to support global pharma operations and ensure timely response to critical laboratory system issu
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