岗位职责：

1.制定招聘计划，逐步建立完善ADC包装团队，包含ADC制剂目检团队和包装团队。

Hiring experts to build up an ADC DP visual inspection team and packaging team.

2.带领团队建立ADC包装科的管理和工作流程，建立相关管理文件。

Leading the establishment of management framework and operation workflow in ADC packaging section.

3.审阅生产计划，安排生产排班，进行生产管理。

Review production plans, arrange production schedules, and conduct on-site management.

4.确保符合和贯彻GMP法规、公司质量标准等要求。

Ensure the production meet with company GMP compliance requirements and the products meet with company quality standards.

5.严格遵守规范要求，解决包装工艺中相关投诉，偏差，调查等。

Address issues such as product complaints, deviations, and process investigations related to packaging processes.

6.领导制剂目检缺陷品库的建立和维护。

Lead the establishment and maintenance of the defective product warehouse for formulation visual inspection.

7.积极参与内外部审计。

Actively participate in internal and external audits.

8.指导和发展团队成员，确保所有团队成员经过良好的培训。制定团队成员发展计划。

Guide and develop team members, ensure all team members receive adequate training. Plan well for team member development.

9.确保所有生产活动符合EHS规范。

Ensure all production activities comply with EHS standards.

10.参与新厂房建设，确保厂房设计，设备选型，和所有的验证工作符合工艺和法规要求。

Participate in the construction of new facilities, participate in the facility design, equipment selection, and all validation works.

资历要求：

药学、生物工程、化学工程、制药工程等相关专业本科及以上学历

Bachelor's degree or higher in Pharmacy, Bioengineering, Chemical Engineering, Pharmaceutical Engineering, or related fields

10年以上制药行业相关工作经验；

More than 10 years of relevant work experience in the pharmaceutical industry;

熟悉灯检流缺陷品库建立和维护流程；熟悉灯检人员资质维护流程；

Familiar with the process of establishing and maintaining the defect libraries for light inspection lines; familiar with the process of light inspection personnel qualifications;

5年以上商业化无菌制剂包装经验；

More than 5 years of experience in commercial DP packaging;

具备药品上市审计应对经验

Experience in responding to questions from regulatory agency audits.

精通无菌冻干制剂的目检和包装工艺；

Proficient in visual inspection and packaging processes;

熟悉生物制剂目检和商业化包装法规要求；

Familiar with the regulatory requirements for visual inspection and commercial packaging for biological products;

具备商业化包装现场管理和排产能力；

Ability of on-site management;

团队管理能力和跨部门协作能力；

Team management and cross-functional collaboration;

具有良好的计划制定和执行能力，能够在压力环境下高效完成任务。

Demonstrate strong ability in planning and execution in a high-pressure environment.