Tech Lead – Controls & Compliance

Tech Lead - Controls & Compliance

Ready to turn bold ideas into real-world impact?
 At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or 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 what’s possible, this is your moment. 
 
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
 Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description

Job Description - Computer System Validation Analyst

Key Responsibilities:

• Use risk based approach and critical thinking in implementing validation approach.
• Provide CSV support to the Quality and Compliance function working closely with Business and IT stakeholders, App and Infra support teams.
• Responsible for supporting the ongoing validation activities across Application landscape
• Provides on-going validation management support to plan, prioritize and deliver system enhancements, general releases, hotfixes, as well as product periodic revalidation.
• Closely collaborate with Application Managed services Team and Business/IT stakeholders to ensure requirements/specifications are defined in a clear, testable, and compliant format
• Effectively work with cross-functional teams (Product Management, Testing, Technical Operations) to ensure the validated state of the system/application is maintained
• Ensure requirements are adequately tested following a risk-based approach
• Identify and log issues found during validation execution. Work closely with Product and Testing teams to identify and prioritize issues early on and track validation incidents to closure.
• Ensure clear traceability against all testing performed
• Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices.
• Independent pre and post-execution review of validation test scripts

• Prepare validation summary reports for executed protocols.
• Updates of the system inventory to ensure that is maintained at all times. e.g., addition of systems, retirement of systems, periodic review dates, etc.
• Management/input of Change Control, CAPA, Deviations.
• Ability to act as responder in audits.

Experience/Skillset Requirements

• Degree (Bachelors or Masters) in Computer/Electrical/Electronics Engineering or other relevant Field.
• Hands-on experience with the validation of commercial, R&D and ERP and Corporate applications used for regulated activities in the pharmaceutical industry
• Knowledge of Agile software development, and software testing methodologies.
• Excellent written and oral communication skills, good decision-making skills, and time management skills.
• Experience with cloud-based applications and/or infrastructure compliance

Qualifications

Bachelors - Commerce, Bachelors - Economics, Bachelors - Finance, Masters - Business Administration, Masters - Business Analytics

Certifications

Certified Information Systems Security Professional (CISSP) - Workforce Academy OnlineWorkforce Academy Online, CISA - ISACA – Information Systems Audit and Control AssociationISACA – Information Systems Audit and Control Association

Required Skills

Agile Methodology, Amazon Web Services (AWS), Client Relations, Collaboration Tools, Cora APFlow, Design Thinking, DevOps, Executive Presence, Inclusion, People Leadership, Personal Effectiveness, Risk Management, ServiceNow Platform, Storytelling

Language

English (Required)

Language Proficiency -

Advanced - C1

Additional Job Location -

Job Type

Regular

Master Skill List -

Controls & Compliance

Remote Type -

Hybrid

Work Shift -

Evening Job (India)

Why join Genpact?
•    Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
•    Make an impact – Help global enterprises solve business challenges that matter 
•    Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
•    Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day 
•    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.  
Let’s 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.