Digital Compliance Expert
Vor 5 Tagen
At TN Switzerland, we are seeking a highly skilled and experienced professional to join our team as an Digital Compliance Expert. The ideal candidate will have a deep understanding of regulatory requirements and industry standards for computerized systems in the pharmaceutical industry.
The successful candidate will work closely with cross-functional teams to design and implement cutting-edge AI/ML/Digital solutions that meet GMP business objectives. This includes developing and maintaining a comprehensive understanding of the organization's technical landscape, data infrastructure, and data processing pipelines.
The key responsibilities of this role include:
- Providing Quality Assurance guidance while designing and implementing AI/ML/Digital solutions in a GMP Environment.
- Developing and maintaining documentation for AI/ML systems, including technical specifications, system architecture diagrams, and user guides.
- Ensuring that AI/ML systems comply with relevant regulatory requirements, such as data privacy laws and industry standards.
- Working closely with stakeholders to identify business needs and requirements and propose technical solutions leveraging AI/ML technologies.
The ideal candidate will possess:
- A BS/MS degree or equivalent in Science or Engineering Field, with years of experience in a regulated industry, such as the pharma/biotech or medical device industry.
- 4+ years of relevant work experience OR An equivalent mix of education and work experience is required.
- Strong knowledge of AI/ML technologies, including deep learning, natural language processing, and computer vision.
- Knowledge of Pharmaceutical Regulations (FDA/EMA) and how they relate to computerized systems (Part 11/Annex 11 Computer Systems Validation).
- Experience with cloud computing platforms such as AWS, Azure, or Google Cloud Platform.
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