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 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 Responsibilities:
- 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
Preferred Skills:
Domain->Healthcare->Regulatory Compliance & Standards,Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV),Technology->Life Sciences->Regulatory Systems,Technology->Risk Management->Risk Management System
