»  Strategy & Consulting »  Principal-Business Consulting-Computer System Validation

10Yrs -15 Yrs       Bangalore / Chennai / Pune / Hyderabad     Openings: 2

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The Company

Our global client is looking for talented and highly motivated consultants to join the Life Sciences consulting practice. 

Key responsibilities:
  • Minimum of 12+ years of professional experience in Life Sciences industry working for a consulting services organization. 
  • Lead strategic business transformation programs, manage program planning, execution and reporting; responsible for program resources, deliverables, quality, stakeholder communication, client buy-in, program risks, mitigations and budgets leading to successful program delivery and client delight
  • Engage with key stakeholders; manage day-to-day interactions with client teams
  • Conduct interviews/workshops/walkthroughs with subject matter experts and process owners to gather information for analysis, recommendations and for preparation of project deliverables
  • Participate in sales pursuits in collaboration with larger Infosys teams; contribute to the proposal development process; proposal content creation and client presentation
  • Develop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals
  • Participate in practice development activities; coach junior consultants; participate in consultant training processes.
Your Profile
  • Demonstrates proven success in roles and thorough abilities in one or more of the following areas:
  1. Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT
  2. Subject matter expertise in areas such as Quality Management, document management and Change Management
  3. Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
  4. Knowledge of Risk management, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures
  5. Knowledge and hands on experience conducting periodic or control maturity assessment and Audits • Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry