:

- 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

- Good 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 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

- 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 skilled experience in the Life Sciences industry working for a consulting services organization and or industry

- Good 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

Technical Requirements:

- 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

Additional Responsibilities:

- 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

Preferred Skills:

Domain->Healthcare->Regulatory Compliance & Standards,Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV),Technology->Life Sciences->Regulatory Systems

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