东莞招聘

职位描述：
职责：
1.负责灭菌供应商的选择和管理
2.负责灭菌过程确认和灭菌产品的放行
3.洁净室的测试及认证管理
4.负责第三方生物兼容性测试报告的审核

要求：
1.有微生物和洁净室工作背景经验
2.必须具有有EO灭菌的过程确认经验，包括IQ/OQ/PQ
3.熟悉消毒包装材料和及其设计，测试及鉴定者优先
 
Description :
1.Has a biology background and may have worked in cleanrooms Hiring could happen around the time that the equipment comes. Could help with installation = IQ, OQ, & PQ.
2.Help with selecting the outside sterilization supplier – this is needed as part of Sterile Packaging
3.Manage sterilization validation and sterile release – we will need to add more QMS procedures to control this activity
4.Cleanroom testing and certification
5.Both facility and product expert for Bioburden and endotoxin issues

Qualification
1.Knowledge of sterile packaging materials beneficial
2.Knowledge of Packaging system design qualification beneficial
3.Knowledge of sterile barrier shelf life / accelerated aging beneficial
4.Knowledge of Sterile packaging/sealing test methods beneficial
5.Sterilization revalidation 举报 分享

卡莱医疗科技（东莞）有限公司是,（以下简称卡莱医疗）是一家专业的医疗线材产品生产厂家。卡莱医疗隶属于美国卡莱集团。卡莱集团是一家实力排行在美国500强内的美国上市公司，旗下的股票业绩在美国纽约有非常出色的表现。