Senior Specialist Quality Control-Analytical lab

Typical Accountabilities

主要职责

Specific Responsibilities/Tasks

 具体职责/任务

Routine work

日常工作

• Mangement of instrument
• Report any deviation timely, lead critical deviation/OOS investigation  
• /OOS的调查
• 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.
• Prepare specification for application (draft) and specification explanation
• Regulatory/change assessment and change management
• Lead function level project
• Cross team communication and support
• SME of QC core system
• QC核心系统的专家
• Quality process champion

S.H.E. Responsibilities

SHE 职责

• Take personal responsibility for security to protect themselves and avoid harm to others and the environment
• Participate the necessary security training and drills with the contingency project
• Strictly enforce the job safety procedures
• Report any incidents , accidents and hazards in work timely
• 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.
• 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.
• 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 lab manager in completing tasks when required.
• Complete other tasks arranged according to business needs

Qualifications资质

Education, Experience and Training

教育、工作经验和培训

• Academic/Professional qualification
• /专业资格

• Minimum requirement a bachelor degree in chemical, pharmaceutical and analysis related subjects
• Technical/skills training 技术/技能训练
• Excellent technical expertise in HPLC, MS, GC, AAS, UV, IR, NIR and other analytical methods in an industrial environment is required. 拥有优秀的专业技术能力，如在工业生产领域掌握HPLC, MS, GC, AAS, UV, IR, NIR等分析技术。
• Knowledge of and experience in analytical development, transfer and validation is required.
• Knowledge of and experience in quality and regulatory requirements under which pharmaceutical products are developed, commercialized and supported.
• Knowledge of global pharmacopoeia and relative regulations, such as ICH, FDA, EMEA regulations is required
  • ICH, FDA，EMEA等。

• 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   

A Bachelor degree with minimum 7+ years industry experience in the analytical area, or A  Master degree with minimum 3+ years experience, or A Ph.D degree with minimum 2+ years experience;

• 7年以上分析工作经验，硕士3年以上，博士2年以上。

• Desirable   理 想

A Bachelor degree with minimum 8+ years industry experience in the analytical area, or A  Master degree with minimum 5+ years experience, or A Ph.D degree with minimum 3+ years experience;

• 8年以上分析工作经验，    硕士5年以上，博士3年以上。

• 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.