Bengaluru, Karnataka
Job Summary
Provide L2/L3 functional support for TrackWise QMS modules (CAPA, Deviations, Change Control, NCR)
Handle incident management, issue analysis, and resolution as part of RTB operations.
Manage ticket queues, SLA adherence, and backlog prioritization.
Support enhancements, configuration changes, and minor developments in TrackWise workflows.
Ensure compliance with regulatory standards (GxP, 21 CFR Part 11) and internal audit requirements.
Monitor and support CAPA closure, audit observations, and deviation tracking.
Perform impact analysis for change requests and coordinate deployments.
Support SIT/UAT cycles for enhancements and defect fixes.
Collaborate with QA, business users, and IT teams for issue resolution and improvements.
Maintain documentation, SOP alignment, and audit readiness artifacts.
Skill Requirements:
Hands-on experience in TrackWise QMS support (RTB / AMS environment)Solid knowledge of:
CAPA Management
Deviation Management
Change Control
Audit & Compliance processes
Experience in incident management tools and SLA-driven support modelUnderstanding of manufacturing / semiconductor domain (preferred for LAM)Knowledge of GxP compliance, CSV/CSA validation practicesStrong troubleshooting and problem-solving skills
Key Responsibilities
Provide L2/L3 functional support for TrackWise QMS modules (CAPA, Deviations, Change Control, NCR)
Handle incident management, issue analysis, and resolution as part of RTB operations.
Manage ticket queues, SLA adherence, and backlog prioritization.
Support enhancements, configuration changes, and minor developments in TrackWise workflows.
Ensure compliance with regulatory standards (GxP, 21 CFR Part 11) and internal audit requirements.
Monitor and support CAPA closure, audit observations, and deviation tracking.
Perform impact analysis for change requests and coordinate deployments.
Support SIT/UAT cycles for enhancements and defect fixes.
Collaborate with QA, business users,
and IT teams for issue resolution and improvements.
Maintain documentation, SOP alignment, and audit readiness artifacts.
Skill Requirements:
Hands-on experience in TrackWise QMS support (RTB / AMS environment)Strong knowledge of:
CAPA Management
Deviation Management
Change Control
Audit & Compliance processes
Experience in incident management tools and SLA-driven support modelUnderstanding of manufacturing / semiconductor domain (preferred for LAM)Knowledge of GxP compliance, CSV/CSA validation practicesStrong troubleshooting and problem-solving skills
Skill Requirements
Provide L2/L3 functional support for TrackWise QMS modules (CAPA, Deviations, Change Control, NCR)
Handle incident management, issue analysis, and resolution as part of RTB operations.
Manage ticket queues, SLA adherence, and backlog prioritization.
Support enhancements, configuration changes, and minor developments in TrackWise workflows.
Ensure compliance with regulatory standards (GxP, 21 CFR Part 11) and internal audit requirements.
Monitor and support CAPA closure, audit observations, and deviation tracking.
Perform impact analysis for change requests and coordinate deployments.
Support SIT/UAT cycles for enhancements and defect fixes.
Collaborate with QA, business users, and IT teams for issue resolution and improvements.
Maintain documentation, SOP alignment, and audit readiness artifacts.
Skill Requirements:
Hands-on experience in TrackWise QMS support (RTB / AMS environment)Strong knowledge of:
CAPA Management
Deviation Management
Change Control
Audit & Compliance processes
Experience in incident management tools and SLA-driven support modelUnderstanding of manufacturing / semiconductor domain (preferred for LAM)Knowledge of GxP compliance, CSV/CSA validation practicesStrong troubleshooting and problem-solving skills
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📌 Technical Specialist (India)
🏢 HCLTech
📍 India