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Senior Life Science Consultant

hace 2 meses

Sevilla, Sevilla, España Johnson & Johnson A tiempo completo
About Us

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality.

Job Overview

We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team.

Responsibilities
  • Provide 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.
  • Design and understand test plans, system, and UAT test scripts, and test procedures for AI solutions.
  • Provide guidance on validation, conduct timely reviews, and escalate to TQ management when necessary.
Requirements
  • 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.
Preferred Skills
  • Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validation.
  • Proficient knowledge of FDA guidance and industry standards (i.e., GAMP).
  • In-depth knowledge and practical experience with AI technologies, specifically Open AI's ChatGPT.
  • Proven experience with AI testing strategies and understanding AI models.
  • QA methodologies and the ability to design, review, and approve test plans, scripts, and procedures.
What We Offer
  • Flat hierarchies and responsibility from the beginning.
  • People-oriented culture.
  • Diversity and inclusion-focused environment.
  • Global client projects in a multinational environment.
  • Flexible working hours and home office.
  • Involvement in global conferences.
  • Individual professional development, training, and coaching.
  • Unlimited full employment contract.
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus.