Job Summary

Mandatory Skills: (Must Have Skills) 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) , 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

Key Responsibilities

Mandatory Skills: (Must Have Skills) 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) , 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

Skill Requirements

Mandatory Skills: (Must Have Skills) 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) , 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

Must Have Skill

Computer System Validation (CSV)

Positive to Have Skill

Other Requirements

📌 Track Manager (Support & Operations) (India)
🏢 HCLTech
📍 India