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ジョブタイプ: Full-time
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仕事内容
- In this position, you will be directly involved in the technical project management and execution of computer system validation engagements in conjunction with the Global Service and Support teams. Efficiency, accuracy, a keen willingness to learn, and the ability to work effectively with multiple stakeholders in a multi-cultural and geographically distributed environment are essential to success in this job.
- Interact with external stakeholders at all levels including laboratory scientists, laboratory technicians, laboratory directors, IT, QA and regulatory staff and/or consultants.
- Master the documentation and execution process behind Computer System Validation.
- Practice continuous PPI thinking.
- Identify opportunities in laboratory workflows and data integrity where the company can offer value-added services to speed production deployment of platforms, increase customer retention and prohibit competitive entry.
- Develop and pilot value-added services and support product commercialization process for these services (PCP).
- Work effectively in an FDA regulated and/or ISO compliant environment.
- Identify areas for process improvement in the development, training and delivery of these services.
- Additional and incidental work related to the primary duties may be required for company business needs from time to time.
- Travel (~30-50%) will be required for customer onsite visits. (global)
- Bachelors or Master’s Degree in a Scientific or Computer Sciences discipline
- In-depth knowledge and experience with performing and/or developing Computer System Validations
- Keen understanding of quality systems and operating in a GMP environment.
- Excellent communication (verbal and written), negotiation, presentation, and interpersonal skills
- Documentation management/generation in a Content Management System a plus
- Working knowledge of statistical methods.
- Working knowledge of global regulated markets (FDA, CLIA, CAP, CFDA, etc).
- Experience with html and /or xml a plus
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締切: 16-07-2024
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