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Senior Life Science Consultant

4 settimane fa

Abruzzo, Italia TN Italy A tempo pieno
Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise, Pescara

Client: Johnson & Johnson

Location: Pescara, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: fe6dce430c7b

Job Views: 9

Posted: 20.02.2025

Expiry Date: 06.04.2025

Job Description:

Overview

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries focused on quality. We are looking for a highly skilled and motivated senior CSV 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, with extensive knowledge in AI solutions, including the utilization of Open AI technologies like ChatGPT.

Responsibilities

  1. Providing consultation services to our clients in the pharmaceutical industry, focusing on computer system validation (CSV) and AI solutions.
  2. Develop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT.
  3. Feed internal procedures & documents into AI systems, ensuring accurate identification of the source.
  4. Deliver insights on regulatory differences across various countries through clear reports and graphical representations.
  5. Develop and execute validation deliverables, including requirements, compliance/validation plans, test protocols, and reports.
  6. Review and approve system tests, user acceptance test scripts, traceability matrices, and design specifications.
  7. Design and understand test plans, system, and UAT test scripts for AI solutions.
  8. Provide guidance on validation and conduct timely reviews.

Minimum Qualification and Experience

Education

  1. Bachelor’s degree in computer science, Data Science, or a related field.
  2. Master’s degree is preferred.

Language

  1. Fluent in English (oral and written) is a requirement.
  2. Any additional language is a plus.

Work experience

  1. 3+ years of experience in Computer System Validation.
  2. 2+ years of experience with System Development Lifecycle.
  3. Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry.
  4. Familiarity with FDA regulations and global regulatory environments.
  5. Understanding of GxP standards and risk-based validation.

Hard Skills

Must Have:

  1. Experience in FDA and/or Global regulated environment with a good understanding of GxP standards.
  2. Proficient knowledge of FDA guidance and industry standards (i.e., GAMP).
  3. In-depth knowledge and practical experience with AI technologies, specifically Open AI's ChatGPT.

Nice to Have:

  1. Exceptional organizational and multitasking skills.
  2. Proven ability to lead a team and work independently.

Soft Skills

  1. Strong written and verbal communication skills.
  2. Ability to work as a team player or independently.
  3. Strong attention to detail and data accuracy.
  4. Capability to work with remote teams and support multiple projects.

We offer great benefits

  1. Flat hierarchies and responsibility from the beginning.
  2. People-oriented culture.
  3. Diversity and inclusion-focused environment.
  4. Global client projects in a multinational environment.
  5. Flexible working hours and home office.
  6. Involvement in global conferences.
  7. Individual professional development, training, and coaching.
  8. Unlimited full employment contract.
  9. Excellent remuneration package with competitive salary plus a substantial bonus.

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, please send your application to recruiting(at)kvalito.ch including your:

  1. CV, cover letter, and supporting documents (i.e., diplomas, certificates, references).
  2. Availability - earliest start date.
  3. Salary expectations.
  4. Location preference.

We look forward to your application.

Your KVALITO Team.

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