Job Overview
We are seeking a highly skilled and motivated professional to join our team as a Senior Life Science Consultant.
Key Responsibilities:
* Provide consultation services to clients in the pharmaceutical industry, with a 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.
Requirements:
* Bachelor's degree in computer science, Data Science, or a related field.
* Master's degree is preferred.
* 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.
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.