Lead Consultant(Product/Domain)
India
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Job Description
Lead Consultant(Product/Domain)
Chennai, Tamil Nadu

Job Summary

  • Must be able to support Business Separation activities for Large global & regional GxP Computerized systems.
  • Must haves: Large scale SAP implementations, J&J experience Recent experience with Acquisitions/Separations/Divestiture from J&J a huge plus.
  • Ability to independently manage end-end from Inventory, assessments, remediations to final dispositions; Infrastrucure Qualifications and Business Systems Validations.
  • 10+ years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs). Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.
  • Ability to provide Validation guidance, timely reviews, and escalations to TQ management

 

Key Responsibilities

1. To develop and deliver ,detailed solutions through consulting project activities
2. To perform qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions
3. To coordinate with Internal and external stakeholders to ensure effective deliver of client specific solution
4. To design,structure and deliver reports and presentations that are appropriate to the characteristics or needs of the audience
5. To cultivate successful customer relationships

Skill Requirements

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Other Requirements

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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 227,000 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 March 2026 totaled $14.7 billion.