Infosys—Principal - Business Consulting

Job description

Description: 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, 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. 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, Skills: 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.