Life Sciences Management Consultant - (GRC)

• • 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

Roles & Responsibilities

• 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
• 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

Technical Requirements

• • 4 – 14 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, or any other applications/system used in Pharma industry.
• • Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)

Additional

• • 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.
• • 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