Track Manager (Support & Operations)

Teknik, data och digitalt · Mjukvaru- och webbutveckling · QA och testning · Mjukvaruutveckling · Verksamhetsanalys

I korthet

HCLTech seeks a Track Manager (Support & Operations) in Noida, India. The role involves strong experience in GxP/IT Validation (CSV/CSA) within regulated environments, GAMP 5, CFR Part 11, and EU Annex 11. Responsibilities include managing change, incident, and deviation processes, authoring documentation, and collaborating with global stakeholders.

Ansvarsområden

Manage IT systems validation as Validation Responsible / Validation Lead.
Implement risk-based validation across Agile and V Model deliveries.
Handle Change, Incident, and Deviation Management, including RCA & CAPA.
Conduct Supplier assessments.
Author, review, and manage validation & compliance documentation.
Collaborate with stakeholders in a global setup.

Krav

Strong hands-on experience in GxP / IT Validation (CSV / CSA) within regulated environments.
Solid knowledge of GAMP 5, CFR Part 11, EU Annex 11 and Novo Nordisk QMS.
Proven capability as Validation Responsible / Validation Lead for IT systems.
Experience in risk-based validation across Agile and V Model deliveries.
Hands-on experience with Change, Incident, and Deviation Management (including RCA & CAPA).
Experience with Supplier assessment.
Working knowledge of tools such as ServiceNow, Veeva Vault / QualityDocs, and validation repositories.
Ability to author, review, and manage validation & compliance documentation.
Strong stakeholder collaboration and communication skills in a global setup.
Ability to work independently with a strong quality and compliance mindset.

Förmåner

Supercharge your potential.
Find your career.
Find your spark.

Färdigheter

GxPIT ValidationCSVCSAGAMP 5CFR Part 11EU Annex 11Novo Nordisk QMSRisk-based validationAgileV ModelChange ManagementIncident ManagementDeviation ManagementRCACAPASupplier assessmentServiceNowVeeva VaultQualityDocsValidation repositoriesStakeholder collaborationCommunication

#Track Manager#Support#Operations#Validation#GxP#IT Validation#CSV#CSA#GAMP 5#CFR Part 11#EU Annex 11#Novo Nordisk QMS#Risk-based validation#Agile#V Model#Change Management#Incident Management#Deviation Management#RCA#CAPA#Supplier assessment#ServiceNow#Veeva Vault#QualityDocs#Noida#Uttar Pradesh#India

Om HCLTech

Supercharging progress through technology and innovation

HCLTech is a global technology company, home to 219,000+ people across 54 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2022 totaled $12.1 billion. To learn how we can supercharge progress for…

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