Job Description:
- 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

Key Responsibilities:
- We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits
- 12 20 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 Oracle Argus ArisGlobal LifeSphere Veeva Vault or any other similar 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

📌 Life Sciences Management Consultant (Bengaluru)
🏢 Infosys
📍 Bengaluru