The Job

Senior Technical Specialist

Teknik, data och digitalt · Mjukvaru- och webbutveckling · Mjukvaruutveckling

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I korthet

Senior Technical Specialist providing L2/L3 functional support for TrackWise QMS modules including CAPA, Deviations, Change Control, and NCR. Responsibilities include incident management, SLA adherence, and ensuring compliance with GxP and audit requirements.

Ansvarsområden

  • 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

Krav

  • Hands-on experience in TrackWise QMS support (RTB / AMS environment)
  • Strong knowledge of CAPA Management
  • Strong knowledge of Deviation Management
  • Strong knowledge of Change Control
  • Strong knowledge of Audit & Compliance processes
  • Experience in incident management tools and SLA-driven support model
  • Knowledge of GxP compliance
  • Knowledge of CSV/CSA validation practices
  • Strong troubleshooting and problem-solving skills

Önskade kvalifikationer

  • Understanding of manufacturing / semiconductor domain (preferred for LAM)

Förmåner

  • Supercharge your potential
  • Find your career
  • Find your spark
  • Be at a place that knows that helping its customers stay on top starts by putting its people first
  • Global technology company with over 223,000 people across 60 countries
  • Industry-leading capabilities centered around digital, engineering, cloud and AI
  • Broad portfolio of technology services and products
  • Work with clients across all major verticals
  • Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion
#QMS#TrackWise#CAPA#Deviations#Change Control#NCR#L2/L3 Support#RTB#AMS#Incident Management#SLA#GxP#21 CFR Part 11#CSV#CSA#Validation
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Företag

HCLTech

Publicerade jobb

för 2 veckor sedan

Anställningstyp

Heltid

Arbetsform

På plats

Erfarenhetsnivå

Senior

Platser

Bengaluru, India

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