北京招聘

1.Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）

Provide the accurate analytical result and report timely for the sample comes from checking and inspecting of the processes of production, in process control, environment monitoring, change control and customer complain, etc. Assist Manager of Microbiology & Bioassay Laboratory to manage of the routine sample, reference standard substances, stability study sample. Implement analytical method validation, instrument maintenance and calibration. Accomplish the investigation and review of the result out of specification within Microbiology & Bioassay Laboratory. Ensure the analytical processes under control and meet the requirement of Roche PMS, Chinese GMP and the related regulation.

对成品生产制造、制程控制，环境监测等过程中的样品进行检验和检查，提供及时、准确的分析结果和报告。协助微生物实验室经理处理日常样品管理、标准品管理、稳定性样品管理，完成分析方法验证，实施分析仪器的维护、校验和保养。完成超标结果调查和复核。确保所有分析过程处于受控状态，符合罗氏总部、中国GMP和有关法规的要求。

2.Principle Roles & Responsibilities / Accountabilities 主要职责/责任

Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time.

完成分配的日常检验样品，在合理的分析周期内签发正确的分析报告。

· By familiar defined analytical methods within working section, comply with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.

熟练掌握工作领域内的指定分析方法，遵守职业道德和操守，确保分析数据的可靠性和完整性，具备良好的工作适应能力。

· By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.

通过工作时间的合理分配，优化待分析样品的组合，保持合理的 分析周期。

· By form a good working habit to standardize experimental operations.

养成良好的工作习惯，规范实验操作。

· By checking analysis result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.

通过认真仔细地复核分析记录，尽量减少差错，保证数据的准确性和可靠性。

Implement the maintenance and calibration of assigned instruments

实施分管仪器的维护、校验和保养工作。

· By accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.

完成指定仪器的维护、校验和保养工作，确保仪器设备随时满足分析需要。

· By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.

保管号相应文件，以便追溯仪器的维护、校验和保养历史以及所有变更

Solve the abnormal status, unexpected results with initiative and in time.

及时主动地向上级通报非正常状况和实验结果。

· By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.

实验过程中发现的非正常状况和实验结果应在第一时间向上级通报详细数据和信息，以提示上级进行调查并及时正确的解决问题。

· By involving the investigation precession to provide actual data and information to helping to provide the same issue happened repeatedly.

参与调查过程，提供真实的数据和信息，以帮助避免类似问题重复出现。

Stick lab safety regulations to prevent occurrence of accident.

严格遵守实验室安全规定，防止意外事故发生。

· By obey the safety instruction of the storage, usage and disposal of reagent, narcotics, medicines, lab waste.

遵守有关试剂、毒品、药品和实验室废物的存储、使用和处置规定。

· By following the usage instruction of facilities of water, electricity and steam etc. in lab.

遵守实验室内对水、电、汽等公用设施的使用规定。

· By clearing the working space in time to follow company safety rule, and patrol working section at the end of working day to secure the safety of lab.

工作日结束时，及时清理工作台，检查相关工作区域，确保实验室安全。

Obey the requirement against global GMP standards and China GMP requirement, to improve the compliance level.

遵守总部和中国GMP要求，完善GPM的实施工作

· By learning of current GMP requirement of Roche PMS, Chinese GMP regulatory, realize the requirement of cGMP and implemented in daily analysis work.

学习最新罗氏总部和中国GMP法规要求，并应用到日常分析工作中。

· By maintaining the documentation to ensure quality system operations in QC meets the regulatory.

通过修订质量文件，确保质量保证部的质量运作体系符合法规要求

3.Qualification and Experience 能力与经验

Education/Qualifications教育程度/所获资格证书

· Bachelor of Science Degree or above 理学士及以上学位

· At least 2 years’ experience in Quality Control Unit of major or joint venture Pharma Company

至少2年在大型或合资制药企业质量控制岗位工作经验

Leadership Competencies领导者胜任力

· Models Integrity倡导诚信

· Focus on value and customer 价值与客户导向

· Align for success 协力成功

· Deliver results 结果导向

· Learn for the future 不断学习

Job Required Competencies岗位所需胜任力

· Professional knowledge of microbiology and bioassay analysis 微生物分析专业知识

· GMP implementation experience and sense GMP实施经验和意识

· Language skills – English & Chinese 语言能力-英语及国语

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。