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INInfosys Consulting - Europe

Senior /Principal Consultant - Validation Lead for SAP Application(m/w/x)

Frankfurt am Main
Full-timeOn-siteSenior

Leading SAP application validation for life sciences clients, including GxP documentation. Stakeholder management and C2 English proficiency required. Training and development opportunities.

Requirements

  • Broad business skill set including stakeholder management, problem-solving, and resilience
  • Experience in gathering, validating, synthesizing, documenting, and communicating data and information for various audiences
  • Excellent interpersonal skills
  • Strong written and verbal communication skills in country's official language(s) (C2 proficiency)
  • Strong written and verbal communication skills in English (C2 proficiency)
  • Project-related mobility/willingness to travel
  • Managing or leading multiple large-scale or complex SAP S/4HANA projects
  • Ability to respond effectively to evolving situations in highly regulated Life Sciences/Pharmaceutical environment
  • Understanding of key pharmaceutical compliance regulations
  • Preferable IT background
  • Eagerness to learn
  • Striving to make an impact

Tasks

  • Lead and execute validation activities
  • Collaborate with clients and internal teams
  • Develop validation strategy and approach
  • Document Software Development Lifecycle Activities
  • Consider GxP and Non GxP elements
  • Recommend risk-based testing approach
  • Ensure system compliance with regulations
  • Provide improvement plans for practices
  • Revise methodology or CSV related SOPs
  • Build integrated project plans
  • Include CSV Lifecycle Deliverables
  • Incorporate quality gates and milestones
  • Provide leadership in critical engagements
  • Drive successful outcomes
  • Use Lean/Agile approaches to validate assets

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishNative
  • rootNative

Tools & Technologies

  • SAP S/4HANA
  • Computerized System Validation
  • 21 CFR Part 11
  • GxP
  • GAMP 5
  • Cloud
  • S4
  • Data Privacy
  • Data Integrity
  • Information Security

Benefits

Learning & Development

  • Training and development opportunities
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