Life Sciences Management Consultant

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
• 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 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

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