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帝博企业管理欢迎最新从事过医疗器械生产/质量管理等行业的优秀人才加入我们,上海帝博企业管理咨询有限公司将为您提供广阔的发展平台!
Validation Supervisor
美国医疗耗材公司新招职位,负责灭菌产品的验证工作
上班地点:上海office 或 江苏home office 或 浙江home office
公司卖点:
1. 稳定的业务 (去年黑石集团联合另2家投资机构对公司进行了投资,可见资本市场对他们发展前景的认可)
2. 他们业务体量在全球所有医疗行业排在第6名,行业壁垒更高
3. 内部发展空间,相比知名的医疗行业公司一个复杂的架构,在公司内部晋升通道能更有机会进入管理层
4.公司个别岗位也会愿意考虑快消,低值耗材行业的人选,对于一些想换赛道到医疗行业的人选,这是个很好的机会
要求:
1. 英文口语流利
2. 熟悉灭菌验证(不管哪种类型的灭菌都可以)
工作职责:
1.Manage new suppliers and products development process that related to sterility assurance in Asia by doing below:
Supplier audit,ETO sterilization validation,Steam sterilization validation,Irradiation validation,Packaging validation
2.Manage existing suppliers and products sterility assurance related activities in Asia by doing below:
Sterilization revalidation,Routine sterilization audit,CAPA, SCAR
3.Collaborate and interact with cross functional teams. Provide technical supports, suggestions, training as needed.
4.Seek opportunities for continuous improvement of processes and techniques. Able to get resources to implement the plan. Update procedures as needed to maintain compliance and improvement.
5.Build the competent team by making and implementing clear team development plans with comprehensively considering the company‘s needs and resources.
职位要求:
1. Bachelor degree or above;major in Biotechnology, Pharmaceutical, Chemical or Engineering
2. 5 years+ of work experience in quality/technical department of health care related company. Experience in validation/qualification activity is an advantage.
3. Knowledge of GMP regulation, AAMI and ISO standards and validation methods is preferred.
4. Microsoft Word and Excel experience at an intermediate level is required
5. Fluently in both oral and written English
6. Willing to travel intensively
7. Project management skill is a plus
五险一金 员工旅游 出国机会 专业培训 通讯补贴 绩效奖金 年终奖金 定期体检