Overview
Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise (Pescara, *****), (Reggio Calabria, *****), (naples, *****), (Bologna, *****), (Bagno Di Romagna, *****), Abruzzo, Calabria, Campania, Emilia-Romagna, Lazio, Sardinia - Italy | Posted - ************
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
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 & 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.
Minimum Qualifications and Experience
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 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
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 premio.
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 recruiting(at)kvalito.ch 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.
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