HCLTech

Consultant

India · On-site
Salary not published
Posted today

From HCLTech's careers page

Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.

About the role

The role provides quality leadership across Design & Engineering, Implementation, and BAU operations for on‑prem, virtual, cloud infrastructure, including large‑scale Server Appliance deployments across global sites.

What they ask for vs. your profile

Must have

Auditing
FDA regulations
AWS
Azure
Presentation skills

Similar jobs

All jobs

HCLTech

Consultant

India · On-site
Salary not published
Posted today

From HCLTech's careers page

Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.

About the role

Job Summary

Job Description: The position is responsible for end‑to‑end CSV Infrastructure Qualification for GxP‑regulated environments, ensuring compliance with FDA, GAMP5, EU Annex 11, and client Quality Systems.
The role provides quality leadership across Design & Engineering, Implementation, and BAU operations for on‑prem, virtual, cloud infrastructure, including large‑scale Server Appliance deployments across global sites.

Key Responsibility

CSV Infrastructure Qualification

GxP compliance across infrastructure lifecycle

Audit readiness and regulatory alignment

Quality oversight for multi‑year, large‑scale Server Appliance implementations

Roles & Responsibilities

Define qualification strategy

Lead and govern execution of Infrastructure IQ, OQ activities.

Ensure vendor documentation and supplier qualification evidence meet GxP expectations.

Oversee change, deviation, and CAPA management during implementation.

Act as Quality SPOC for project audits and client reviews.

Ensure right‑first‑time qualification and inspection‑ready documentation

Govern ongoing compliance of qualified infrastructure in BAU.

Perform and oversee: Periodic reviews, Change impact assessments and requalification decisions, Incident, deviation, and CAPA oversight

Ensure infrastructure changes, patches, and upgrades follow controlled CSV processes.

Maintain continuous audit readiness for BAU environments.

Technical & Regulatory Expertise

Show the full description

GAMP 5, FDA 21 CFR Part 11, EU Annex 11

Infrastructure Qualification (on‑prem, virtual, cloud)

Data Integrity (ALCOA+)

Risk‑based validation and lifecycle management

Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage)

Experience

Minimum 10 years of experience in Computer System Validation

Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments

Capabilities and Certifications

Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure)

Must Demonstrate Good Communication and Presentation Skills

Key Responsibilities

Key Responsibility

CSV Infrastructure Qualification

GxP compliance across infrastructure lifecycle

Audit readiness and regulatory alignment

Quality oversight for multi‑year, large‑scale Server Appliance implementations

Roles & Responsibilities

Define qualification strategy

Lead and govern execution of Infrastructure IQ, OQ activities.

Ensure vendor documentation and supplier qualification evidence meet GxP expectations.

Oversee change, deviation, and CAPA management during implementation.

Act as Quality SPOC for project audits and client reviews.

Ensure right‑first‑time qualification and inspection‑ready documentation

Govern ongoing compliance of qualified infrastructure in BAU.

Perform and oversee: Periodic reviews, Change impact assessments and requalification decisions, Incident, deviation, and CAPA oversight

Ensure infrastructure changes, patches, and upgrades follow controlled CSV processes.

Maintain continuous audit readiness for BAU environments

Skill Requirements

Technical & Regulatory Expertise

GAMP 5, FDA 21 CFR Part 11, EU Annex 11

Infrastructure Qualification (on‑prem, virtual, cloud)

Data Integrity (ALCOA+)

Risk‑based validation and lifecycle management

Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage)

Experience

Minimum 10 years of experience in Computer System Validation

Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments

Capabilities and Certifications

Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure)

Must Demonstrate Good Communication and Presentation Skills

Other Requirements

Apply now

Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 230,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, 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 2026 totaled $14.8 billion.

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What they ask for vs. your profile

Must have

Auditing
FDA regulations
AWS
Azure
Presentation skills
Customer experience
Manufacturing
Regulatory compliance
SAP
Spark

What they ask for vs. your profile

Must have

Auditing
FDA regulations
AWS
Azure
Presentation skills

Consultant

About the role

What they ask for vs. your profile

Must have

Similar jobs

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Why HCLTech?

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Must have

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Your match

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