Who are we?

- Infosys is a global leader in next-generation digital services and consulting with annual revenues of $16.31B (FY ‘22). We enable clients in 46 countries to navigate their digital transformation
- Infosys Consulting partners with clients from strategy through execution to transform their businesses in areas such as business/ IT strategy, processes, organization, systems and risk. Infosys Consulting has 2,500+ people across the US, Europe, APAC and India
- We are Value Integrators – we deliver realized business value by managing transformations from strategy / setting direction through execution, including operating and optimizing delivered solutions
- IC-LS is dedicated to serving Life Sciences firms globally.

What are we looking for?

We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity and passion for excellence. Our analysts have a blend of in-depth domain expertise, strong analytical and conceptual thinking skills and excellent soft skills.

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation, Risk Management and Audits

- 4 – 14 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
- Positive understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
- Experience creating, reviewing and approving / acknowledging validation deliverables.
- Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
- Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Trackwise, QMS, DMS and etc.
- Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR,



or any other applications/system used in Pharma industry.
- Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)
- Experience in Agile and waterfall methodology
- Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits
- Knowledge in Saas/Cloud Qualifications
- Knowledge of validation tools and templates used in the pharmaceutical industry.
- Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
- Preferable IT background to understand complexities on the program.
- Preferable work experience with Major IT firms or Big 4.

Good to have:

- AI/ML Validation Strategy & Execution - Hands-on experience in defining and executing risk-based validation approaches for AI/ML and Generative AI-enabled GxP systems, ensuring alignment with CSA, GAMP 5, and regulatory requirements.
- AI Model Lifecycle Governance - Establish and oversee controls for AI model lifecycle management, including model performance monitoring, drift detection, retraining, change control and revalidation activities.
- Validation of Intelligent Automation Solutions - Lead validation of AI-powered solutions such as OCR, Intelligent Document Processing (IDP), NLP, predictive analytics, and Generative AI applications used in regulated business processes.
- AI Compliance & Risk Management - Perform AI-specific risk assessments addressing explainability, bias, hallucination risks, data integrity, traceability,



and regulatory compliance to ensure business-critical AI outputs remain reliable and compliant.
- Cloud AI Platform Validation - Support qualification and validation of cloud-based AI platforms and services (AWS Bedrock, SageMaker, Azure OpenAI, etc.), including supplier assessment, infrastructure controls, and GxP compliance reviews.

What will you do?

At IC-LS, you will:

- Be responsible for the delivery of business results to global health and life sciences clients.
- Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
- Execute consulting engagements in a global delivery model, working with consultants across regions.
- Analyze problems and structure complex business analyses.
- Work with cross functional client teams to perform gap analysis and identify improvement options.
- Effectively collaborate with the internal and external stakeholders.
- Participate in a variety of firm building events.

What do we require?

We are searching for success-oriented people who have a consulting mindset, strong analytical skills, a competitive drive, and an entrepreneurial spirit that will help propel the continued growth of the firm. We look for candidates that have prior relevant work experience, excel in ambiguous situations, and possess a passion for helping companies become more competitive. Business acumen combined with a comfort with technology is a must as well as robust verbal and written communication skills.

Candidates must be able to quickly frame complex business problems and prioritize root causes with confidence, but not arrogance. We pride ourselves on hiring consultants that immediately fit into the fun yet professional atmosphere of Infosys. We value intellectual curiosity, initiative and entrepreneurial drive!

Candidates must be open to domestic and international travel as per program requirements.

Where are we hiring?

Multiple Locations

📌 Consultant (Bengaluru)
🏢 Infosys Consulting
📍 Bengaluru