Lead Consultant â CSV Analyst
Lead Consultant â CSV Analyst
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Job Description
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 innovationour teamsimplementdata technology and AItocreate tomorrow today.Get to know us atand onLinkedInXYouTube 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 (cGMPs 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 140000 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.
Required Experience:
IC
Employment Type
Full-Time
