Lead Consultant(Product/Domain)

Experience: 3 to Not Available years

Location: Chennai, India

Skills: Computer System Validation, GxP Regulations, FDA, Risk based validation, JIRA, ServiceNow, XRAY, QA Methodologies, Test Plans, UAT test scripts, Test procedures, Test scripts, defect reviews, team player, lead a team, Validation guidance

Job Summary
Role- CSV Lead
PS- Computer System Validation, GxP Regulations
SS- Validation experience with Medical Devices and Infrastructure Qualification
Experience in validating Medical Devices and Infrastructure Qualification
3+ years’ experience with System Development Lifecyle
7+ years’ experience in Computer System Validation (Based on the role selected)
Experience in FDA and/or Global regulated setting with good understanding of GxP standards and Risk based validation.
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
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.
Preferred tools knowledge and experience: JIRA, ServiceNow, XRAY and Change Record review
Experience in Acquisition, Separation and Divestiture
Experience in Infrastructure Qualification
Should be experienced in Test scripts, executions and defect reviews.
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

📌 Lead Consultant(Product/Domain) (Chennai)
🏢 HCL Technologies
📍 Chennai