北京招聘

1. Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）
Perform the microbiological testing on the samples from incoming raw materials and packaging materials, produced bulks and products, environment monitoring, process validation, cleaning validation, stability study and customer complaint, etc. Provide the accurate analytical result and report timely. Execute analytical method validation, instrument maintenance and calibration. Attend the investigation of the result out of specification when needed. Ensure the analytical processes under control and meet the requirement of Roche PQS, Chinese GMP and other related regulation.
对进厂原辅料和包材、生产的半成品和成品、环境监测、工艺验证、清洁验证、稳定性研究和客户投诉等过程中的样品进行微生物检验，提供及时、准确的分析结果和报告。执行分析方法的验证，实施分析仪器的维护保养和校验。必要时参加超标结果的调查。确保所有分析过程处于受控状态，符合罗氏PQS、中国GMP及其他相关法规的要求。
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 master 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
By keeping contact with instrument company to obtain the sufficient
application technical support and repair service in time.
保持与仪器公司联系，以及时获得足够的仪器应用的技术支持。
Report the abnormal status, unexpected results to supervisors 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***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 prevent 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。
Guide colleagues to fulfill analysis tasks.
协助同事完成分析任务。
By providing technical support to colleagues if necessary share
knowledge and experience within working section.
需要时向同事提供技术支持，分享工作领域内的知识和经验。
Complete the assigned analysis method validation.
完成分派的分析方法验证
By initiate the assigned analysis method validation, to implement
planning, and issue the validation report.
通过计划、实施和报告阶段启动指定的分析方法验证工作。
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 PQS, 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QC的质量运作体系符合法规要求
1. 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
Project management
skills 项目管理能力
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。

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