Specialist Quality Control (Analytical Lab)

Typical Accountabilities

主要职责

Specific Responsibilities/Tasks

Routine work 日常工作

• Finish the routine analytical work accurately and timely
• undefined
• Issue the analytical method transferring and validation protocol for raw materials finish products etc.,
• undefined
• Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status.
• undefined
• Double-checking the BAR.
• undefined
• Responsible for the management of chemical reagents/ reference standard/ consumables, including purchase and maintenance of safety inventory
• undefined
• Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances
• undefined
• Keep the chemical lab tidy and clean at any time.
• undefined
• Report any deviation timely, lead major deviation/OOS investigation
• undefined
• Stability study management
• undefined
• 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.
• undefined
• Prepare specification for application (draft) and specification explanation
• undefined
• Maintenance of QC E-system eg. GQCLIMS,1Lab, Empower
• /Empower
• New employee training
• undefined
• Issue technical assessment report
• undefined
• Lead team level CI project
• undefined

S.H.E. Responsibilities

SHE 职责

• Take personal responsibility for security to protect themselves and avoid harm to others and the environment
• undefined
• Participate the necessary security training and drills with the contingency project
• undefined
• Strictly enforce the job safety procedures
• undefined
• Report any incidents , accidents and hazards in work timely
• undefined
• Purchase/ store/ use controlled chemicals.
• undefined

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.
• undefined
• 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.
• undefined
• 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.
• undefined
• 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

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工作经验

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.