(Senior) Analyst of P/C Lab
Roche
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Complete adroitly the assigned routine inspection of sample, issue the reliable analytical report in reasonable Lead-time.
熟练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 good capacity of working suitability.
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 assigned lead-time.
通过工作时间的合理分配,优化待分析样品的组合,保持分配的分析周期。
· 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 analytical 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 GMP compliance against global GMP standards and China GMP requirement
根据总部和中国GMP 要求,完善GPM 的实施工作
· By assisting lab. Manager to conduct GMP Self- Inspection, and executive the implementation action to maintain the global level of GMP compliance.
协助实验室经理实施GMP 自查,执行改进实施计划,维护全球性的GMP 实施水平
· By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory.
通过维护质量体系和文件系统,确保质量控制部的质量运作体系符合法规要求
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.
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。
· By keeping contact with instrument company to obtain the repair service in time.
保持与仪器公司联系,以及时获得及时的维修服务。
· 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, 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。
· By providing technical support to junior analyst, if necessary share knowledge and experience within working section.
需要时向 初级分析员提供技术支持,分享工作领域内的知识和经验。
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, steam and 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。
Implement the analysis method validation.
实施分析方法验证
· By implement the assigned analysis method validation according to validation plan.
根据计划执行指定的分析方法验证工作。
· Sampling of cleaning validation.
进行清洁验证的取样工作。
Have the basic ability to find and solve the problems occurred in the routine work.
在日常工作中具有发现问题并解决问题的基本能力。
· To find the problems and solve the problems in correct way and in time during the analysis processing.
在实验过程中发现问题并能及时准确地解决问题。
· To ensure the normal running of routine work.
以确保工作的正常运行。
Education/Qualifications 教育程度/所获资格证书
· Bachelor’s Degree (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred)
学士学位( 生物,微生物,生物化学,化学及相关学科优先)
· Graduate or higher-level Degree is preferred
更高学历优先
Leadership Competencies 领导力
· 3 or more years’ work experience in the pharmaceutical or related industry
3 年以上制药或相关企业经验
· 3 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry
3 年以上制药行业质量、合规或相关经验
Job Required Competencies 岗位所需胜任力
· Good knowledge of analytical laboratory operations in support of commercial manufacturing.
良好的分析实验室操作的相关知识来支持商业生产
· Good knowledge of cGMP relevant to the pharmaceutical industry
良好的制药行业相关的cGMP 知识
· Expert knowledge of laboratory safety procedures
专业的实验室安全知识
· Strong knowledge of Quality System principles, practices and standards for the pharmaceutical industry
较强的制药行业质量体系原则,实践和标准的知识
· Demonstrate basic verbal and written communication skills in English
表现出基本的英语口语和书面沟通能力
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Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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