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Senior Life Science Consultant
hace 2 meses
We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team.
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.
- 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.
- 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.
