Senior System Validation Consultant

Há 2 dias


Lisboa, Lisboa, Portugal Capgemini Tempo inteiro

Unlock the full potential of computerized systems in the Life Sciences sector. We're seeking a seasoned expert to lead Computer System Validation initiatives, ensuring compliance with regulatory requirements and maintaining system integrity. This role is ideal for individuals with experience in Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS), with strong analytical skills and attention to detail.

About the Role

This position involves working closely with our clients to assess and mitigate risks associated with computerized systems. You'll be responsible for conducting thorough risk assessments, impact analyses, and ensuring adherence to regulations such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Your expertise will play a critical role in shaping our approach to CSV and driving business growth.

Requirements
  • Proven experience in Computer System Validation within the Life Sciences industry
  • Familiarity with MES and LIMS systems preferred
  • In-depth knowledge of regulatory requirements
  • Strong analytical and problem-solving skills
  • Excellent documentation and communication skills
  • Good command of English
About Capgemini

At Capgemini, we empower our employees to shape their careers and drive innovation. Our collaborative community offers diverse opportunities for growth, access to cutting-edge technologies, and a supportive environment that promotes work-life balance. Join us in unlocking the value of technology and building a more sustainable, inclusive world.



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