CSV Lead CSV Lead …

in Brussels, Bruxelles-Capitale, Belgium
Permanent, Full time
Be the first to apply
in Brussels, Bruxelles-Capitale, Belgium
Permanent, Full time
Be the first to apply
CSV Lead
Job Summary

  • Validation Lead will be responsible for End to End validation activities
Key Responsibilities

  • Validation planning, execution & closure of GxP and Non-GxP applications
  • Prepare Validation Plan and Validation Report
  • Ensure that the system is validated and used in a compliant manner. Ensure that appropriate user procedures are in place.
  • Knowledge in performing Risk Assessments
  • Monitor and assist validation and release related progress of the project through to closure
  • Prepare, review and approve project deliverables in accordance with validation Plan
  • Maintain constant interaction with business users, systems owners, technical writers and SME to analyse requirements and to develop Validation plan
  • Performed Planning, Scheduling, prioritizing, assigning and monitoring the Validation testing activities.
  • Develop, review and approve the test cases to check if all the functional and Compliance requirements are met
  • Effectively Manage Defects
  • Developed Requirements Traceability Matrix (RTM) to map the functional requirements, design specification and the OQ/PQ test script references
  • Proactively raised Risks and provided corrective and preventive action.
  • Effectively report the daily and weekly project status to the project stakeholders
  • Develop the Summary Report to provide a summary of the Validation testing activities and executed deliverables
Job Requirements

Essential Skills:

  • Strong understanding of Eudralex, 21 CFR, GxP requirements including electronic records, electronic signatures, system validation strategies and Documentation
  • Strong knowledge and background of Software Development Life Cycle (SDLC) and SDLC models like V model, Iterative, Waterfall and Agile
  • Experience with HP ALM and JIRA
  • Experience in Validation testing and performed system testing, integration testing, user acceptance testing, black box testing, functional testing (manual and automation), back-end, Data migration and Regression testing.
  • Experience in leading Validation Projects.
Nice to Have Skills.

  • Automation Testing

  • As Required by Cognizant.
Travel required :

  • No
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