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Ass. Engineer, Chemical

地点 泰州市, 江苏, 中国 职位 ID R-193152 发布日期 02/27/2024

Purpose

准确及时地完成原辅料、成品的检验并保证产品在效期内符合质量标准;

将仪器维护在良好的工作状态及发展专业技能;

协助分析方法开发和解决问题;

从专业的角度参与验证,风险评估和偏差调查等活动。

Finish routine analytical work for raw materials and finished products accurately and timely to ensure fulfill the specification during shelf life.;

Maintain the instruments in good status and develop professional skills;

Assist in method development and trouble-shooting;

In charge or involve in validation, risk assessment and deviation investigation as specialist.

Responsibilities:

  • 完成日常的化学/微生物检验任务,如产品物料的检测,环境监测和常规的公用系统的检测;
  • Conduct routine chemical/micro test such as product, material, EM, utility.

  • 起草,复核或更新相关的SOP,检验方法和质量标准
  • Prepare, reviewand updated related SOPs, test method and specifications

  • 起草仪器的确认方案,实施仪器的确认试验并完成确认报告,例如实验室仪器的安装/运行/性能确认和再确认
  • Prepare the qualification protocol, conduct the qualification activities for equipment and complete the qualification report, such as IQ/OQ/PQ or re-qualification for Lab equipment.

  • 参与技术转移工作,实施分析方法转移并完成分析方法转移报告
  • Participate the technical transferring ,conduct the analytical method transferring work and complete the analytical method transferring report

  • 起草分析方法验证/确认方案,实施相关测试,完成验证/确认报告,例如工艺验证,清洁验证,药典方法确认等
  • Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.

  • 作为实验室计算机系统的本地管理员,清洁,维护试验仪器,联系供应商或合适的承包商完成仪器的确认或校验,以确保仪器设备处于良好状态
  • As local administrator of laboratory computerized system, Clean, maintain the equipment and contact with supplier or proper contractor to qualify/calibrate the equipment to keep in good status.

  • 作为试剂管理员和对照品管理员协助化学实验室耗材管理,包括试剂,对照品,玻璃仪器,个人防护用品等Assist in As administrator of reagent and reference standard, management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
  • 复核检验记录,必要时协助OOS调查Perform analytical record double-checking and assist in OOS investigations when necessary.
  • 起草新员工的培训方案和确认计划并实施培训
  • Prepare the new staff training plan and qualification plan for new staff and conduct the training.

  • 协助SHE管理,确保试验室各项活动符合公司SHE的政策
  • Assist in SHE management to keep the lab to be in conformity with company SHE policy.

  • 完成其他指定工作
  • Complete other assigned tasks

  • 积极参加由内部或外部组织的系列培训活动
  • Participate actively in serials training required to be held by internal and external.

  • 发展各种工作技能并追求持续的改进Develop all kinds of skills in relation to work field and pursue continuous improvement
  • 严格执行化学室的相关标准作业程序和规章制度
  • Follow related SOPs and regulations strictly in chemical lab.

  • 及时按照SOP的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性
  • Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.

  • 积极参加对自检中所发现缺陷的整改Take part in actively in correction to the observations found in self-inspection.
  • 作为阿斯利康泰州供应基地的一名员工,每一位员工对其本人与他人的业务行为、健康与安全、环境保护、帮助公司持续改进绩效和声誉负有相应的责任。因此,每一位员工必须As an employee in Taizhou Supply Site, everyone should be responsible for health and safe、environment protection of him/herself and colleagues, assist company to continually improve the performance and reputation. According to this, every employee should:

  • 理解其业务活动中涉及安全、健康及环境的相关内容以及该活动可能对整个公司的安全、健康环境绩效产生的影响。
  • Understand the business activities related to the content of safety、health and environment, and the appropriate effects to the entire company’s safety, health and environment.

  • 参加培训并提出必要的培训需求,确保其业务活动的安全、合法,保护环境。
  • Attending the training and raise necessary training requirements, ensure the safety, compliance of the business activities, and the protection of environment.

  • 持续表现符合政策的安全、健康与环境行为,并通过交流与沟通,持续改善安全、健康与环境的绩效。
  • Continually demonstrate the behavior corresponding withpolicy of safety, health and environment, also continually improve the performance of safety, health and environment through interpersonal communication.

  • 严格执行本岗位的安全操作规程,并按要求正确使用劳动防护用品,拒绝违章指挥,切实做到“四不伤害”,即不伤害自己,不伤害别人,不被别人伤害,保护别人不受伤害;
  • Strictly follow the job’s safety operation process, and use articles for labor protection correctly, refuse commanding against rules, achieve the goal of “No Hurts FOUR”, neither hurt oneself, nor hurt others, do not be hurt by others, and prevent others to be hurt

  • 可以向您的直接经理或通过行为准则帮助热线就您工作中遇到的安全、健康与环境的有关问题及建议、他人的相关表现以及公司的安全、健康环境绩效进行沟通。
  • You can report to your line manager or use the hotline of code of conduct to communicate with the encountered safety, health and environment issues, also company’s safety, healthy environment performance can be communicated.

  • 采取积极的、正确的态度真实地、准确地填写有关安全、健康与环境绩效的记录以及相关文件,并进行汇总、提交、保存,这有利于公司对所设定目标的进展进行准确地评估,并将评估信息与相关方或其他相关人员进行分享。Adopt the positive, right attitude to fill in related documents about safety, health and environment performance correctly, summarize, submit and save them. These activities will help to evaluated company’s goal accurately, and it will also be shared with interested parties or other related people.


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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