Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise

Johnson & Johnson; Andalucía; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A global Life Science consulting firm is seeking a Senior Life Science Consultant with expertise in Computer System Validation and AI solutions. The ideal candidate will have over 3 years of experience in the pharmaceutical industry and a Bachelor's degree in a related field. The role offers competitive compensation, flexible working hours, and a supportive corporate culture. Apply now to join a diverse team dedicated to quality in regulated industries.

Servicios

Flat hierarchies

Flexible working hours

Diversity-focused environment

Professional development opportunities

Excellent remuneration package

Global client projects

Formación

• 3+ years experience in Computer System Validation.
• Strong understanding of System Development Lifecycle.
• Fluent in English, with additional languages as a plus.

Responsabilidades

• Provide consultation services in computer system validation and AI solutions.
• Develop and implement AI solutions using advanced technologies.
• Ensure compliance with regulatory standards through detailed documentation.

Conocimientos

Experience in FDA regulations

Knowledge of GxP standards

Proficient in AI technologies (Open AI's ChatGPT)

QA methodologies

Exceptional organizational skills

Strong verbal communication

Educación

Bachelor’s degree in computer science or related field

Master’s degree (preferred)

Herramientas

Open AI's ChatGPT

Descripción del empleo

Overview

Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise [Andalusia, ], [Zaragoza, 50001], [Santander, 39001], [León, ], [A Coruna, ], Cantabria, Andalusia, Aragon, Castille and León, Galicia - Spain | Posted - 13 / 07 / 23

We are looking for enthusiasts

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland, Italy, and Malaysia. With our enthusiasm for progressive technologies and our in‑depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch

Position

Life Science Consultant: Senior CSV (AI Focus)

Only candidates located within the European Union (EU) will be considered for this position.

Duration: 6 months (with the possibility of extension)

Responsibilities

• 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 and 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

Qualifications

Education

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

Language

• Fluent in English (oral and written) is a requirement
• Any additional language is a plus

Work experience

• 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

Hard Skills

Must Have:

• 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

Nice to Have:

• Exceptional organizational and multitasking skills
• Proven ability to lead a team and work independently

Soft Skills

• Strong written and verbal communication skills
• Ability to work as a team player, lead a team, or complete tasks independently
• Strong attention to detail and ability to ensure data accuracy and reliability
• Capability to work with remote teams and support multiple projects simultaneously

We offer great benefits

• 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

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to [e-mail] including your:

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

We are looking forward to your application.

Your KVALITO Team.