岗位职责:

1.熟悉方法确认、转移和验证流程。确保检测所使用的方法经过确认、验证或转移。

Familiar with the processes of method verification, transfer, and validation. Ensure that the methods used for testing are confirmed, validated, or transferred.

2.组织方法验证、转移和测试过程中发生的实验室事件、OOX和偏差调查。

Organize lab event, OOX, and deviation investigations occurring during method validation, transfer, and testing processes.

3.起草所有与项目管理有关的变更（包括验证，方法和规格变化等），跟踪CAPA及时执行。

Draft change control related to project (including validation, method, and specification changes), and track the timely implementation of CAPA.

4.制定项目计划，能够有条不紊地执行多项任务，及时跟踪项目进展，确保项目有序推进，按时交付。

Develop project plans, execute multiple tasks in an organized manner, track project progress timely, ensure project proceeds smoothly, and deliver on time.

5.具备新分子样品的测试能力(包括不仅限于：寡核苷酸、多肽的色谱和质谱分析)。

Testing capability for new modality (Including but not limited to: LC, GC and MS test for Oligo and Peptide).

6.参与客户审计和政府审查，及时完成发现项的整改。

Participate in client audits and government inspections, and promptly complete corrective actions for identified findings.

7.具备跨团队沟通能力，与客户加强沟通，建立稳定良好的关系。

Experience in Cross-team communication, strengthen communication with clients, and establish stable and positive relationships.

任职要求:

1Master

s degree or higher in pharmacy or chemistry-related fields

2Familiar with pharmaceutical production, testing, and quality management, as well as GMP-related regulations

3 Proficient in English, fluent in speaking, with smooth expression and the ability to communicate independently

4Proficient in computer skills, including excellent PPT creation and presentation abilities