Responsibilities岗位职责:

1.负责制定ADC包装科的组织机构以及人员配置，明确各岗位的职责，处理ADC制剂科的日常事务。

Responsible for formulating the organizational structure and personnel allocation of the ADC Packaging Department, clarifying the responsibilities of each position, and handling the daily affairs of the ADC Formulation Department.

2.审阅生产计划，安排生产排班，进行现场管理。

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

3.确保包装生产所需的物料、备品备件提前准备，以及做好SAP系统的及时输入和维护

Ensure that materials and spare parts required for packaging production are prepared in advance, and that the SAP system is timely input and maintained.

4.确保符合和贯彻GMP法规、公司质量标准等要求，安全地进行药品目检和包装生产，保证药品的质量。

Ensure compliance with and implementation of requirements such as GMP regulations and corporate quality standards, conduct safe visual inspection and packaging production of pharmaceuticals, and guarantee the quality of pharmaceuticals.

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。

Strictly abide by regulatory requirements, and address issues such as complaints, deviations, and investigations related to packaging processes.

6.参与文件制备,例如SOP, MBR ,和流程管理。

Participate in document preparation, such as SOPs (Standard Operating Procedures), MBRs (Manufacturing Batch Records), and process management.

7.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.

8.积极参与内外部审计。

Actively participate in internal and external audits.

9.确保ADC包装科人员接受过与所从事工作相适应的培训并取得相关资质。

Ensure that personnel in the ADC Packaging Department have received training appropriate to their work and obtained relevant qualifications.

10.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, and formulate team member development plans.

11.确保所有生产活动符合EHS规范。

Ensure that all production activities comply with EHS standards.

12.协助公司其他部门进行各种注册、临床、稳定性样品的包装制作

Assist other departments of the company in the packaging of various registration, clinical, and stability samples.

13.参与新厂房建设，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 workshops, and ensure that workshop design, equipment selection, and all validation work meet process and regulatory requirements.

10年以上制药行业相关工作经验；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；5年以上商业化无菌制剂包装经验；具备药品上市审计应对经验

精通无菌冻干制剂的目检和包装工艺；

熟悉生物制剂目检和商业化包装法规要求；

具备商业化包装现场管理和排产能力；

团队管理能力和跨部门协作能力；

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。