Lead Consultant(Product/Domain)

Experience: 6 to Not Available years

Location: Chennai, India

Skills: Computer System Validation, Quality management, Business Analysis, GxP application, Validation Deliverables, Validation Compliance Plan, RTM, Data Flow Map, Change Controls, Requirement Analysis, UAT Authoring, audit support, Application Lifecycle Management, JIRA, qTest, SNOW, risk identification, risk mitigation, Good Clinical Practices, GCP, FDA 21 CFR Part 11, agile, waterfall, iterative software development, incremental software development, Analytical skills

Job Summary
6+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
Developing validation strategy for projects
Good Knowledge on Requirement Analysis and UAT Authoring
Providing audit support and support Application Lifecycle Management
Managing/guiding/overseeing periodic checks
Ability to guide cross-functional teams and mentor junior staff
Broad experience in Computer System Validation (CSV) and testing
Acquainted with Valuable Clinical Practices (GCP)



regulatory requirements and FDA 21 CFR Part 11
Clear written and verbal communication, especially for technical documentation
Acquainted with both the agile and waterfall software development methodology
Solid understanding of the fundamentals of iterative and incremental software development
Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
Skilled in project planning, execution and minimal rework strategies
Capable of risk identification and mitigation, especially in regulated environments
Strong Analytical and Problem solving

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