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SHDM Technician, Formulation配液技术员

Job Description

Mission/Position Headline:        

l  Responsibilities include the execution of a wide range of manufacturing work instructions and related procedures, which vary in complexity and process types as well as maintaining highly accurate documentation of all operation steps performed.  This position must also provide calculation and GMP witnessing for the work of others in the formulation group.负责生产部门配制岗位操作规程及相关SOP的具体操作,确保相应文件、记录真实、准确,按照操作规程的要求准确计算并对配制岗位其他人员的工作进行复核。

l  Critical skills for success in this role include having a strong mathematical background, exceptional attention to detail, and an ability to effectively cooperate with multiple operations in parallel within defined time ranges.本岗位要求有较强的计算能力,严格执行岗位操作规程要求,能够在一定时限内同时和不同生产职能人员进行有效沟通和协作。

职责领域 Areas of Responsibilities:

l  The job specific activities include preparation of buffer solutions, final preparation of immunoassay reagents and cleaning&sterilization. 工作范围包括缓冲液配制、主试剂配制,工器具清洗和灭菌处理。

l  The operations are performed in a clean room environment as GMP required, and require proper aseptic technique.  The common equipment involved in operations mainly include pH meters, electronic balances, micro pipettes, conductivity meters,  spectrophotometers, vacuum and pump based filtration systems, COP station and autoclave.生产环境为洁净区,要求具备一定的GMP洁净室操作技能。涉及的设备主要包括pH计、电子天平、微量移液管、电导率仪、分光光度计、蠕动泵及过滤系统、清洗工作站和灭菌柜。

l  Strictly follow  production schedule  and orders, Work Instructions step by step and complete production records timely according to GDP (Good Documentation Practice) to ensure product quality during routine production.日常生产过程中,根据生产计划及生产指令,严格按照操作规程规定的操作步骤进行操作,遵守GDP要求及时、保质完成生产记录的填写,确保产品质量符合要求。

l  Identify continuous improvement opportunities and process improvement initiatives. Engage in 5S management and participate in Lean activities within work area.具备持续改进的意识,参与工艺改进活动,如工作区域5S管理、精益管理等活动。

l  Fully compliant with company EHS requirements.遵守公司EHS政策和要求。

l  Timely to report NC and actively involve in CAPA activities, assist superior to ensure timely investigation and solution of quality issues.

l  及时报告不符合事件,积极参与至纠正和预防活动中,协助上级对质量问题进行调查、分析和解决。

l  Other related projects or tasks assigned by superior or company.其它上级交代的任务。

教育和经验Education and Experience

经验Experience

l  Graduate from college or university or typically less than 2 years experience in IVD or pharmaceutical related positions.大专或本科毕业生或2年以内体外诊断试剂或制药相关岗位操作经验。

l  Microsoft Office experience required.微软办公软件使用要求

教育Education  

l  College or vocational school education or above; major in Biological Sciences, Pharmacy, Chemical, Mechatronics or related field.大专及以上学历,生物、药学、化学、机电等专业.



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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