Job Responsibilities/工作职责

1. Participate in continuous improvement of the validation related management documents and process, such as validation master plan, system validation plan and validation related SMP. Participate in the improvement of the validation system and process

参与验证相关管理文件和流程的改进，如验证主计划，系统验证计划和验证相关SMP。参与改进验证体系和流程

2. Lead to prepare and update validation related SOP

领导编写和升级验证相关SOP

3. Lead the execution of qualification and validation for the facilities, utilities, system, and APS. Ensure the qualification and validation meet GMP requirements

领导完成厂房设施，公用设施，系统和APS的确认和验证的执行。确保确认和验证符合GMP要求

4. Lead to complete the new equipment qualification activity, including URS, risk assessment, D/I/O/PQ and ensure the qualification meet GMP requirements.

领导完成新系统的确认工作，包括URS，风险评估，D/I/O/PQ，确保确认符合GMP要求

5. Support to update validation schedule related to facilities, utilities, equipment (system) and APS.

协助更新厂房设施，公用设施，设备（系统）和APS相关的验证时间表

6. Participate to handle the training and quality events (deviation/CAP/change control) in validation team

参与处理验证组的培训和质量事件（偏差/CAPA/变更）

7. Participate in the audit with VA and QA team

与验证组和QA一起参与审计

8. Support the recruiting and management of Validation Staff.

协助验证人员的招聘和管理

9. Support to set validation budget and manage expenditure in line with budget, including purchase of test equipment and consumables.

协助制定验证部预算和根据预算管理支出，包括采购测试设备和耗材。

10. Participate in Computerized System Validation work in collaboration with Subject Matter Experts;

与主题专家合作，参与计算机化系统验证工作

11. Participate in the FAT and SAT work

参与FAT和SAT工作

12. Participate in the EHS related work and ensure zero injuries for validation and QA staff

参与EHS相关工作，确保验证和QA员工零工伤

13. Participate in the qualification work in new project

参与新项目的确认工作

Job Requirements/岗位要求

1. Bachelor degree and above or equivalent; plus a minimum of 2 years of experience in validation within pharmaceutical or medical device industries or at least 3 years of pharmaceutical industry experience without formal qualifications experience；

本科及以上或同等学历；具备至少两年制药或医疗器械行业的验证经验，或无验证经验但有至少三年制药行业经验。

2. Understand validation and qualification process defined in cGMP, regulation and other guideline such as ISPE commissioning and qualification.

理解cGMP，法规和其他指南中定义的验证和确认流程，如ISPE调试和确认。

3. Understand the operation principle of critical systems (e.g. heat and steam sterilizers, isolators, PW, WFI, Pure Steam, Compressed Gasses, HVAC).

理解关键系统（如热力和蒸汽灭菌器、隔离器、PW、WFI、纯蒸汽、压缩气体、HVAC）的操作原理。

4. Basic understanding of analytical instrument qualification.

对分析仪器确认有基本了解。

5. Ability to independently prepare qualification protocol and execute qualification test

具有独立起草确认方案和执行测试的能力。

6. Basic knowledge of Good Engineering Practices encompassing system design, factory testing, and commissioning.

具有基本的工程实践知识，包括系统设计、工厂测试和调试

7. Proficient in common Microsoft office and other working software

精通微软office和其他工作软件

8. Basic English reading and writing skills.

基本的英语读写能力