Senior Specialist Quality Control (Micro Lab)

Specific Responsibilities/Tasks

具体职责/任务

Lab routines

常规实验室工作

• BAU arrangement

实验室常规工作的安排

• GQCLIMS releaser

GQCLIMS检验报告释放

• Cross team communication and support

跨团队沟通和支持

• Procedure/protocol/assessment line approver

流程方案报告的批准

• Lead function/site level project

领导部门或工厂级别的项目

• Lead deviation investigation (Critical)

领导重大偏差的调查

• OCM (major)

重大变更管理

• Team management and coach

协助团队管理和指导

• Audit support (audit preparation and readiness check)

审计支持（审计准备和确认）

• Process owner and global network contact

流程负责人以及全球联系网络联络人

• People/team development

人员和团队发展

• Regulatory/change assessment

支持法规和变更评估

• Sampling/testing strategy review and continuous improvement

取样测试策略的回顾和持续改进

SHE Responsibility

SHE 职责

· Take personal SHE responsibility

承担个人安全职责，保护自己，并避免伤害他人和环境

· Participate SHE training and rehearsal

参加该岗位的必须的安全培训并配合应急预案的演练

· strictly following SHE procedure

严格执行岗位安全操作规程

· Report on any SHE accident and hazard in a timely manner

及时汇报工作中的任何事故事件和危险源

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

其它

• Assist the lab manager in completing tasks when required.

需要时，协助实验室经理的工作

• Complete other tasks arranged according to business needs

根据业务需要完成安排的其他工作

• Maintain good 5S in office or work area

维护办公及工作区域良好5S

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

Education, Qualifications, Experience

教育、资质、经验

· Bachelor degree in microbiology or related subjects

本科以上学历，微生物学或相关专业

· Advanced microbiological analysis techniques

较强的微生物分析技能

· 7 year working experience in pharmaceutical company; Experience in M-lab

7年以上制药公司微生物室经历

· 8 years working experience in pharmaceutical company; Experience in M-lab

8年以上制药公司微生物实验室经历

Capabilities

能力

· Fluent English skill in both oral and written

流利的英文交流和读写能力

· Good computer skill

良好的计算机能力

· Good communication and presentation skills

良好的沟通和展示技能

· Good team work spirit, sense of responsibility and work actively

良好的团队合作精神，富有责任心及工作积极

· The Engineer should assist/support the lab manager in leading the associated teams, when required.

有能力协助实验室经理管理整个实验室团队

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.