Description
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Job Function:
QualityJob Sub Function:
R&D/Scientific QualityJob Category:
ProfessionalAll Job Posting Locations:
Suzhou, Jiangsu, ChinaJob Description:
The Senior Scientist is responsible for supporting the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products within Global Orthopedics.高级研究员负责支持端到端的污染控制和无菌保证措施,以开发新产品和/或支持全球骨科的商业产品。
▪ Sterility Assurance technical areas supported include: 无菌保证技术领域支持包括:
▪ Aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation.无菌加工、清洁和消毒要求,灭菌验证(EO、gamma、电子束、湿热灭菌,干热灭菌)、再处理、微生物测试,支持灭菌过程的验证和维护以及产品标签要求(例如生物负载、无菌测试、内毒素监控),环境控制和监测,水和空气系统验证。
▪ sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.无菌保证支持新产品开发和投放,遵守无菌保证和实验室相关领域的适用法规和标准。为审查和提交提供技术支持和风险评估。
Required Skills:
Preferred Skills:
Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing
