附件 1， SOP-1-0044,版本 001

Attachment 1, SOP-1-0044,Ver 001

工作描述
JOB DESCRIPTION

工作描述编号 版本号 001

JD No. Version No. 001

职 位 名 称：微生物工程师 部 门：质量保证部
Position：Microbiology Engineer Department: QA

直 接 主 管: 日期
Immediate Manager Date of approval

上一级经理 日期
Next Level Manager Date of approval

人力资源部经理
日期
HR Head
Date of approval

员工 签字 日期
Job Holder Signature Date of Acceptance

工作目的 Job Purpose

概述工作的目的或角色及其在机构内的价值
Summarizes the job’s purpose or role and why it exists in the organization

协助 QC 经理筹建新实验室。根据 AZ 全球，GMP 和相关法规要求来建立，更新和执行微生物检测和环

境监控程序。给实验室和工厂员工提供专业技术培训和指导。并且从微生物专家的角度参与验证，风险
评估和偏差调查等活动。
To support QC facilitator establishes the new facility. Build, develop, and perform the microbial test
and environmental monitoring program that compliance to AZ Global, GMP and pharmacopeia
requirement. Provide technical guidance and training to lab colleagues and/or product personnel. In
charge or involve in validation, risk assessment and deviation investigation as microbiological
specialist.

工作性质及范围 NATURE & SCOPE

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组 织 机 构 Organization structure

QC 经理
QC Facilitator

微生物工程师
Microbiology Engineer

运作汇报 Operational reports to (请 注 明 职 位 名 称 Please specify position title)

QC 经理
QC Facilitator

功能汇报 Functionally reports to

N/A

直接下属岗位 Immediate Subordination Title

N/A

主要工作关系 Key Working Relationships

- 内部联系 Internal Contacts Within AZ

1） 微生物实验室内部 Microbiological lab

 与实验室内部人员进行日常工作交流；必要时提供实验技术支持和指导，提高他们的业务水平。
Communicate with lab staff on daily basis. Provide the technical support to them, and help them to
improve their professional knowledge and skills
 给实验室人员进行培训或再培训
Perform the training and re-training to the lab staffs
2） QA 部门 QA Department
 提供实验室数据，配合 QA 进行偏差调查和报告
Provide QC test data, and work with QA for deviation investigation and report
 定期联系，及时实行 CAPA 和变更
Routine communication, execute CAPA and change control in a timely manner
1) 生产及其他部门 Manufacture and other Departments
 提供微生物及相关知识的培训
Provide training about Microbiological knowledge and/or associated skills
 及时反馈不良的微生物测试结果，并配合其他部门做调查
Contact other department when the adverse event occur, and provide professional suggestion in
the investigation
 参加跨部门会议，QC 方面的建议。
Attend cross function meeting, and offer recommendation in microbiological perspective.

- 外部联系 External Contacts With Organizations Without AZ

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与一些官方机构，供应商，检查团和一些兄弟公司就分析技术进行交流。
Meet with government, supplier, auditor and other global companies are required.

工作要求 Job Requirement

- 学历/专业资格 Academic/Professional Qualification

本科以上学历，医药学，生物学，微生物学或相关专业。
Bachelor degree or Master degree in a science/technical field such as Pharmacy, Biology,
Microbiology.

- 技术/技能训练 Technical/Skills Training

在制药领域具有综合的微生物知识，包括微生物测试，环境监控，验证等
了解制药行业的质量体系，GMP 和药典的要求
Comprehensive knowledge of microbial testing, environmental monitoring, validation, etc. in
Pharmaceutical area
Knowledge of Quality System, international GMP and pharmacopiea in Pharmaceutical area

工作经验 Working Experience

- 必需 Essentials
制药或相关行业 5 年以上微生物分析工作经验
5 years or more work experience as microbiologist roles in Pharmaceutical industry or
associated industries.

- 理想 Desirable
具有跨国公司以及无菌产品生产的工作背景，熟悉 GMP，GLP 和药典
Experience work in sterile product and/or international companies, familiar with GMP,
GLP and pharmacopeia.

语言能力 Language Ability

具有商务英语的能力
English at a business level

电脑知识 Computer Literacy

熟悉电脑操作，及微软 Word, Excel, PowerPoint 等软件

Good Computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint
etc.

其他 Others
具有工作热情及良好的团队合作精神
Passion for Customers and Works Collaboratively

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关键职责
(按重要顺序排序) 主要任务 绩效显示
Key Responsible Key Tasks Performance Indication
Areas
(in order of
importance)
- 实验在限定的时间内开展并完成
日常测试及检验 - 根据相关的 SOP 或标准测试方法执
Tests performed within the required
行日常必须的测试 timeframe
Routine testing and
Analysis Perform the necessary tests - 保证所检测的环境在控制的范围
according to the relevant SOP/Test
内，公用系统正常的运行。
Methods
Ensure the clean environment in a
- 执行环境监测和常规的公用系统的
state of control, and the clean utility
检测 working well
Perform routine environmental - 实验记录正确完整符合 GMP 要求。
monitoring in clean room and test
Documentation is accurate and
the clean utility system
completed, meet the GMP
- 严格执行实验和实验结果记录 requirement
Document the tests and results in - 产品在限定的时间里正确的从微生
the associated system
物实验室放行
- 必要的时候积极参与偏差调查活动
Batches released appropriately and
并提供相关技术支持 within agreed timeframe
Carry out the investigation and - 测试过程中严格按照 SOP，GMP，
provide the technical support as
GLP 和 SHE 要求进行
required
Adherence to SOPs in test
- 协助 QC 经理管理微生物实验室日
procedures and compliance with
常工作 GLP, GMP and SHE
Coordinate QC facilitator maintain
the routine operation of microlab

验证 - 创建，执行，维护和持续改进在微 - 保证实验室的仪器在规定的时间内
生物保证方面的质量体系 正确的安装和验证
Validation
Develop, implement, maintain and Ensure the equipment install in the
continuously improve the microbial lab correctly and validated in
assurance (microbiology and agreed time lines.
sterilization) aspects of the Quality - 确保测试用的方法符合 AZ 全
System. 球,GMP 和中国药典的要求
- 负责微生物实验室设备，方法或其 Ensure the test method complies to
他系统的验证和再验证 regulatory, GMP and corporate
Lead the validation and/or requirements
revalidation activities for the - 保证微生物实验室的仪器定期校验,
Microlab equipment, test methods 所使用的仪器都在校验期内
or any other system. Microlab equipment is calibrated
- 控制并协调微生物室内仪器的校验 base on the schedule, and all used
活动 equipment are within calibration
Manage the calibration activities for due date.
equipment in microbiological lab

- 所撰写的文件符合 GMP，法规和
文件管理和培训 - 相关文件的撰写，如实验方法，
AZ 全球的要求
Documentation and SOP，验证文件等
training Documentation complies to GMP,
Prepare associated documents
regulatory and AZ global
such as Test Method, SOP,
requirement
validation protocol etc.
- 微生物实验室人员能根据要求正确
- 给实验室人员提供相关的培训及技

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术支持 的使用仪器和进行微生物检验
Provide training and advice to Microlab staff can operate the
microlab staffs, and assistance to equipment correctly and apply
them as required correct test procedures in
- 为其他部门人员提供微生物相关知 accordance to SOP/Test Method
识的培训 - 其他部门的人员理解基础的微生物
Provide microbiological knowledge 知识
to other departments. Other department staff understand
basic Microbiological knowledge
- 微生物实验室现行标准符合法规和
利益相关方 - 保持正确的质量控制体系
GMP 要求
Maintain the appropriate Quality
Stakeholder Focus Microlab meet the regulator and
Control System
GMP requirement.
- 事件事故汇报情况
安全环境健康责任 - 承担个人安全职责，保护自己，并
Report safety issues and accident
避免伤害他人和环境
SHE responsibilities - 无重大安全事故
- Take the SHE responsibility
No serious safety accident
- 参加该岗位的必须的安全培训并配
合应急预案的演练
- Attend required SHE training and
rehearsal
- 严格执行岗位安全操作规程
- Strictly following SHE procedure
- 及时汇报工作中的任何事故事件和
危险源
Report any SHE accident and
hazard in a timely manner

胜 任 能 力 COMPETENCIES

学习能力 持续学习并有专研精神，获取新的技能和知识，学以致
用，付诸于实际工作中。
Learning ability
Continuously learning and study the new technology, ,
and using it in the practice.

沟通技巧 积极主动与同事交流和合作，共同实现目标
communication skill Pre-activity communicate with workmates to fulfill the
goal.

良好的时间管理和独立工作能力 有效的管理自己的工作时间，主动的参与到工作中去
Time management and self driven Effectively manage the work load in a timeframe, and
work effectively without supervisor

 建议直线经理与员工就工作描述进行沟通。
It is suggested that Immediate Manager should communicate the JD with jobholder and get
jobholder’s acknowledgement.
 以上内容用于描写任职者所开展的工作及其基本的特性。这并不是任职者所有职责，技能的清单。
任职者根据指派完成工作描述以外的工作
The above descriptions are intended to describe the general nature and level of work being
performed by incumbents. They are not intended to be an exhaustive list of all duties,

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responsibilities and skills required by all incumbents. Incumbents may perform other duties as
assigned.

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