Lead Consultant – CSV Analyst

Ready to build the future with AI?

At Genpact, we dont just keep up with technologywe set the pace. AI and digital innovation are redefining industries, and were leading the charge. Genpacts AI Gigafactory, our industry-first accelerator, is an example of how were scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges.

If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of whats possible, this is your moment.

Genpact (NYSE: G) is anadvanced technology services and solutions company that deliverslastingvalue for leading enterprisesglobally.Through ourdeep business knowledge, operational excellence, and cutting-edge solutions we help companies across industries get ahead and stay ahead.Powered by curiosity, courage, and innovation,our teamsimplementdata, technology, and AItocreate tomorrow, today.Get to know us atgenpact.comand onLinkedIn,X,YouTube, andFacebook.

Inviting applications for the role of Lead Consultant CSV Analyst

In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution.

Responsibilities

Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met

Evaluate proposed changes to validated computer systems and recommend level of validation activities required

Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology

Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan

Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release

Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

Execution of validation plans and validation documents

Qualifications we seek in you!

Minimum Qualifications / Skills

• BE/B Tech

Preferred Qualifications/ Skills

Familiar with writing tests for Web-based software architectures

Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent).

Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus.

Critical thinker and problem-solving skills

Team player

Good level in English

Great interpersonal and communication skills

Why join Genpact?

• Lead AI-first transformation Build and scale AI solutions that redefine industries

• Make an impact Drive change for global enterprises and solve business challenges that matter

• Accelerate your careerGain hands-on experience, world-class training, mentorship, and AI certifications to advance your skills

• Grow with the best Learn from top engineers, data scientists, and AI experts in a dynamic, fast-moving workplace

• Committed to ethical AI Work in an environment where governance, transparency, and security are at the core of everything we build

• Thrive in a values-driven culture Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.

Lets build tomorrow together.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.