Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Shanghai

Description

Acquire the latest information about Roche global standard, Chinese GMP and the related regulation, to ensure the regulatory compliance.
及时获得罗氏总部、中国GMP和有关法规的最新要求,以确保法规符合性。
Implement the GMP documentation preparation ,printing,sorting and archive,make sure the latest version documents are used in QC.
完成规定的GMP 相关文档的准备、打印、整理、归档等工作,确保QC使用最新版本的文件
Reasonable archiving of the official documents,timely retrieve the old version document to ensure that the current version document is used in QC
合理归档分发的正式文件,及时回收失效文件,以确保QC使用最新版本的文件
Maintain a controlled document list, to ensure the current version documents are available in QC.
维护受控文件列表,使当前版本储存在相应的区域。
Binding of analytical records and ensure the document integrity
分析记录装订及确保文件符合GMP完整性。
Prepare,binding ,archive of logbooks,records,registration in the master logbook and records.
日志、记录的准备和装订,归档及登记到主日志和主记录上。
Sorting and archive documents in the document center,support QC colleagues for QC documents review,borrow in the document center.
文件中心QC文件的整理归档,支持QC同事在文件中心对QC相关文件的查询和借阅。
support the management of GMP sample E2E in QC lab. Ensure samples are compliance with relative regulations from production sampling, login, distribution to final disposing
支持实验室GMP样品端到端的管理。确保样品从生产抽样、登记、分发到最终销毁符合相应的法规要求
Ensure daily sample management and handle any emergency case to support routine business.
确保日常样品管理并处理紧急事件保证日常工作业务运行。
GMP compliance implementation
GMP符合性
Acquire the latest information about Roche global standard, Chinese GMP and the related regulation, to ensure the regulatory compliance.
及时获得罗氏总部、中国GMP和有关法规的最新要求,以确保法规符合性。
Retention sample and reference sample
留样和参考样品管理
Responsible for regular retention and reference retention management, including storage, registration, sorting, annual inspection, disposal, status check,  retention sample room temperature and humidity  monitoring, and related deviation investigation, QRM, SOP.
负责常规留样和参考留样的管理包括入库,登记,库位整理,年检,销毁,状态检查,留样间温湿度监控,以及相关偏差调查,QRM, SOP。
Manage stored reagents/consumable in normative way
规范的试剂/耗材管理
Reagents receipt, labeling ,log in LIMS, locate right position
试剂入库接收,贴入库标签,LIMS 登记,并放置到规定的库位
Deliver the reagent ordered by analyst, ensure the expiry management in line with regulations
根据分析员领用要求,发放试剂,确保试剂的效期管理符合规定
Check the stock, and keep clean
试剂库盘库,并保持试剂库整洁
Toxics management, expired reagent disposal, SHE data summary
剧毒品管理,过期试剂销毁,SHE数据汇总
Use LPS method to establish and maintain the pull system to manage the reagents/consumable
应用LPS(精益)方法建立和维护试剂/耗材的拉动系统
Other work assigned by supervisor
上级领导布置的其他工作
Ensure QC sample flow to ensure GMP Compliance. Compliance to the written instruction, procedure. Implement the maintenance and calibration of assigned instruments. GMP sample and reagent management. Perform documents (such as SOP) preparation and review.
确保QC样品流符合GMP相关要求,以支持业务需要。遵循书面指南和规程。实施分管仪器的维护、校验和保养工作。GMP样品和试剂管理。执行有关文件(如SOP)的起草和复核工作。

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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