Specialist Quality Control (Analytical lab)

Brief Job Description 工作描述简述

Finish routine analytical work for products accurately. Maintain the instruments in good status, and develop professional skills. Finish routine management of reference standards / reagents / consumables to support lab tests performed smoothly.

Manage specification and test method for raw materials, packaging materials and finished products in AZ China to secure the compliance with GMP, cooperate and regulatory requirements. Support other department for regulatory registration.

Understand/follow/own of testing process, identify and report issue/risk within the process and drive improvement, and solve the problem within process scope.

准确及时地完成产品的检验; 将仪器维护在良好的工作状态，发展专业技能; 完成对照品、试剂等易耗品的日常管理，确保实验室检验工作顺利进行。

管理阿斯利康中国公司的原辅料、包装材料和成品的标准和检验方法，以确保符合药品生产质量管理规范和法规要求及阿斯利康的有关规定，协助有关部门进行质量标准法规注册。

理解、遵守、负责综合测试流程; 识别、汇报综合测试流程中的问题和风险，并驱动其持续改善; 能解决综合测试流程内出现的问题。

During contract manufacturing, conduct on-site supervision of quality control-related activities for AstraZeneca products, ensuring comply with quality specification, test methods, and regulatory requirements.

在委托生产期间，对阿斯利康产品检验相关活动进行现场监督，确保符合质量标准和检验方法等法规要求。

Typical Accountabilities

主要职责

Routine work

日常工作

• Finish the routine analytical work accurately and timely 准确及时地完成日常分析工作
• Issue the analytical method transferring and validation protocol for raw materials finish products etc., 起草原辅料/成品等分析方法转移和验证方案
• Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status. 按计划定期做好仪器的维护和验证工作并使其处于良好状态。
• Double-checking the BAR. 复核批化验记录
• Responsible for the management of chemical reagents/ reference standard/ consumables, 负责化学试剂/对照品/易耗品的管理包括采购及维护安全库存
• Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances 负责实验室废弃物品/过期试剂/剧毒品的处理和处置
• Keep the chemical lab tidy and clean at any time. 保持化学室在任何时候的整齐和清洁
• Report any deviation timely, lead major deviation/OOS investigation 及时报告偏差、领导复杂偏差/OOS的调查
• Stability study management 稳定性研究管理
• Issue and revise specification, test method and batch analysis record of starting materials and finished products, and purchasing specification, test method for PQ, CQ etc. 制（修）定原辅料、成品的质量标准、检测方法和批化验记录，原 辅料采购标准，工艺验证和清洁验证检测方法
• Prepare specification for application (draft) and specification explanation 起草申报质量标准草案和起草说明
• Maintenance of QC E-system eg. GQCLIMS,1Lab, Empower 负责实验室系统中数据维护，如GQCLIMS/1Lab/Empower
• New employee training 新员工的培训
• Issue technical assessment report 起草技术评估报告
• Lead team level CI project 领导小组级别改善项目

S.H.E. Responsibilities

SHE 职责

• Take personal responsibility for security to protect themselves and avoid harm to others and the environment 承担个人安全职责，保护自己，并避免伤害他人和环境
• Participate the necessary security training and drills with the contingency project 参加该岗位的必须的安全培训并配合应急预案的演练
• Strictly enforce the job safety procedures 严格执行岗位安全操作规程
• Report any incidents , accidents and hazards in work timely 及时汇报工作中的任何事故事件和危险源
• Purchase/ store/ use controlled chemicals. 危化品的采购、保管、使用 GMP compliance GMP 符合性
• Strictly following SOP and Guideline 严格执行岗位操作规程和指南
• Take GMP training and strictly following GMP compliance 参加GMP培训，严格遵守GMP与法规要求
• Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs. 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
• Take part in actively in correction to the observations found in self inspection. 积极参加对自检中所发现缺陷的整改

Training and development

培训和发展

• Participate actively in serials training required to be held by internal and external. 积极参加由内部或外部组织的系列培训活动。
• Develop all kinds of skills in relation to work field and pursue continuous improvement 发展各种工作技能并追求持续的改进 Others 其他
• Assist the senior engineer in completing tasks when required. 需要时，协助高级工程师的工作
• Complete other tasks arranged according to business needs 根据业务需要完成安排的其他工作

Qualifications资质

Education, Experience and Training

教育、工作经验和培训

Academic / Professional qualification 学历/专业资格

Bachelor or above 本科或以上学历

• Technical / skills training 技术/技能训练 Basic GMP, GLP knowledge; Experience in QC 基本的GMP, GLP知识及QC经验
• Working experience 工作经验 (No. of years /年 资, Job function /工作功能, Business types/业务种类 ) - Essential 必需 More than 4 years working experience in pharmaceutical company or related industry 4年以上制药企业或相关行业的工作经验 - Desirable 理想 More than 5 years working experience in pharmaceutical company or related industry

5年以上制药企业或相关行业的作经验

Capabilities

能力

• Language ability/ 语言能力 Fluent English skill in both oral and written 流利的英文交流和读写能力
• Computer literacy/电脑知识 Good computer skill 良好的计算机能力
• Communication ability/ 沟通能力 Good communication and presentation skills 良好的沟通和展示技能
• Others/ 其他 Good team work spirit 良好的团队合作精神 Sense of responsibility and work actively 富有责任心及工作积极

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.