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Senior Life Science Consultant Specialist

2 settimane fa

Roma, Lazio, Italia Tn Italy A tempo pieno

Job Description

We are seeking a highly skilled Senior Life Science Consultant with expertise in AI to join our team.

The ideal candidate should have proven experience with system development, lifecycles, computer system validation, and regulatory standards. Additionally, the candidate should possess extensive knowledge in AI solutions, including the utilization of Open AI technologies like ChatGPT.

The successful candidate will be responsible for providing consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions.

  • Develop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT.
  • Feed internal procedures & documents into AI systems, ensuring the system accurately identifies the source.
  • Deliver insights on regulatory differences across various countries and present these findings through clear and concise reports and graphical representations.
  • Develop and execute validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports.
  • Review and approve system tests, user acceptance test scripts, traceability matrices, and design specifications.

Requirements

The ideal candidate should have:

  • A Bachelor's degree in computer science, Data Science, or a related field.
  • Master's degree is preferred.
  • Fluent in English (oral and written) is a requirement.
  • Any additional language is a plus.
  • 3+ years of experience in Computer System Validation.
  • 2+ years of experience with System Development Lifecycle.
  • Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry.
  • Familiarity with FDA regulations and global regulatory environments.
  • Understanding of GxP standards and risk-based validation.