DP 目检SME-无锡

最低任职要求Minimum Requirement

教育程度/经验Education background/ Experience

硕士及以上，生物，化学工程，食品，制药，机械工程/自动化相关专业

Master or above, biology, chemical engineering, food, pharmaceutical, mechanical engineering/automation related specialty

硕士：1年以上专业领域经验

Master: Over 1 year of experience in a specialty area

其他要求Other requirements

精通制剂生产流程及岗位生产操作步骤；精通一类及以上设备或GMP生产流程；独立完成SOP/MBR的撰写; 掌握技术转移放大风险点及流程；

Possesses strong expertise in GMP pharmaceutical manufacturing, with hands-on experience in equipment operation, documentation development (SOPs/MBRs), and technology transfer scale-up.

2. 工作职责JOB RESPONSIBILITY

1、负责DPM目检审计相关工作，可独立面对客户和法规审计

Responsible for visual inspection–related audit activities for DPM, with the ability to independently interface with customers and regulatory inspections

3、熟悉西林瓶、预充式注射器半自动灯检机及全自动灯检机等制剂生产设备的工作原理

Familiar with the working principle of manufacturing equipment such as semi-automatic visual inspection machine and automatic visual inspection machine for vial & pre-filled syringe.

4、熟悉人工目检、半自动目检以及全自动灯检的相关标准操作规程

Familiar with the standard operating procedure of MVI, SAVI and AVI.

5、参与/管理工序文件升版及维护。

Participate in and/or manage the revision and maintenance of process documentation.

6、熟悉制剂验证的基本概念，法规指南要求。

Familiar with the basic validation concept and the requirements of regulation and guidance.

7、熟悉cGMP法规要求。

Familiar with the requirements of cGMP regulation.

8、根据需要领导团队合规审计和巡检，并与所有员工一起倡导公司合规&EHS精神

Lead team compliance audits and inspections as needed, and actively promote the company’s compliance and EHS culture in collaboration with all employees.

9、根据需要积极参与风险评估和团队偏差调查，保证团队生产质量。

Actively participate in risk assessments and team deviation investigations as required, to ensure and maintain production quality.

10、良好的英语读/听/写能力，通过CET-6、雅思、托福或其他同等英语考试者优先

Good command of English in reading, listening, and writing; CET-6, IELTS, TOEFL, or equivalent English proficiency certification is preferred.