Senior Technical Lead
India
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Job Description
Senior Technical Lead
Chennai, Tamil Nadu

Job Summary

  • Resources are expected to help with compliance projects for updates to Quality Workbench (GAMEs).
  • Looking for an offshore resource to support a fast-paced ongoing validation project to complete by the end of this year.
  • Some of the high-level requirements for this role are - A senior consultant with expert knowledge of GxP and Computer System Validation.
  • Expertise in authoring and reviewing all CSV validation deliverables.
  • Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
  • Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc.
  • Knowledge with validation of analytics platforms preferred.
  • Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
  • Expertise in SOP and WI authoring and reviews.
  • Proficient with change control management and utilization.
  • Prefer an individual with great communication skills, ability to work proactively and independently.
  • Ability to interact and lead conversations and meeting with Business Partners independently to lead and guide GxP policies and regulations.

Interact with technology partners to ensure compliant working and operation of supported GxP systems.

Key Responsibilities

  • Resources are expected to help with compliance projects for updates to Quality Workbench (GAMEs).
  • Looking for an offshore resource to support a fast-paced ongoing validation project to complete by the end of this year.
  • Some of the high-level requirements for this role are - A senior consultant with expert knowledge of GxP and Computer System Validation.
  • Expertise in authoring and reviewing all CSV validation deliverables.
  • Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
  • Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc.
  • Knowledge with validation of analytics platforms preferred.
  • Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
  • Expertise in SOP and WI authoring and reviews.
  • Proficient with change control management and utilization.
  • Prefer an individual with great communication skills, ability to work proactively and independently.
  • Ability to interact and lead conversations and meeting with Business Partners independently to lead and guide GxP policies and regulations.

Interact with technology partners to ensure compliant working and operation of supported GxP systems.

Skill Requirements

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 223,000 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 June 2026 totaled $14.8 billion.