杭州招聘

Role 职位：CSV Engineer 计算机化系统认证工程师（应届毕业生）

Position Summary 岗位概述:

This position is responsible for helping the customer establish and improve the Quality Management System (QMS) by utilizing the existing Quality procedures and adding industry best practices, maintaining and fine-tuning QMS along the way, form Quality team, and ensuring the all computerized systems at the customer company comply with Regulatory requirements (e.g. US FDA 21 CFR Part 11, EU GMP Annex 11, and CFDA GMP Appendix I), follow industry best practice (e.g. GMAP 5), and the customer company’s QMS.

这个职位是负责利用现有的质量程序和添加生产中的***实践，维护和调整质量管理体系，形成质量团队，并确保在客户公司的所有计算机化系统符合监管要求(如FDA 21 CFR Part 11，欧盟GMP Annex 11和CFDA GMP附录I)，遵循行业***实践(GMAP 5)，以及客户公司的质量管理体系，帮助客户建立和完善整个质量体系。

Responsibilities 工作职责:

· Works with customer IT representatives, end users, clients and field application specialists, product representatives, and field engineers to development CSV plans.

与客户IT代表、最终用户、客户和现场应用专家、产品代表和现场工程师一起制定CSV的计划。

· Works with customers and other project team members to create, modify and finish validation deliverables (e.g. Validation Plan, Design Review Report, Test Plan & Reports, IQ/ OQ Protocol and Reports, etc.) to meet specific customer needs.

与客户和其他项目团队成员一起创建、修改和完成验证交付成果(如验证计划、设计评审报告、测试计划和报告、IQ/ OQ协议和报告等)，以满足客户的特定需求。

· Provides GXP instrument and software validation consulting services to customers based on the established Professional Services project management methodology.

根据已建立的专业服务项目管理方法，为客户提供满足GXP要求的仪器和软件验证咨询服务。

· Works with customer IT representatives, end users, clients and field application specialists, product representatives, and field engineers to solve validation failures, and writes proposed solutions and remedy responses based on customer requirements and business needs.

与客户IT代表、终端用户、客户和现场应用专家、产品代表和现场工程师一起解决验证故障，并根据客户需求和业务需求编写建议的解决方案和补救响应。

· Develops “best practices” for various phases of validation project lifecycle and trains the customer based on training materials developed as part of a validation project.

为认证项目生命周期的不同阶段进行优化，并根据作为认证项目的一部分开发出来的培训材料培训客户。

· Reports task and/or project status to the project manager(s) as needed by the project manager(s).

根据项目经理的要求，向项目经理报告任务和/或项目状态。

Required Interactions 工作交流:

· Client personnel – gathering requirements, understanding business processes, and reviewing processes with customer.

客户人员——收集需求，理解业务流程，与客户一起回顾流程。

· Project managers – report project progress and project-related issues on a timely basis.

项目经理——及时报告项目进度和项目相关问题。

· Field Application Specialists (FAS)/Field Service Engineers (FSE) – support engineers.

现场应用专家(FAS)/现场服务工程师(FSE) ——支持工程师。

· Third-party consultants – communicate requirements, oversee work activities, ensure product/deliverable quality.

第三方顾问——沟通需求，监督工作活动，确保产品/交付品的质量。

Qualifications and Education 任职资格:

· Bachelor or above degree in Chemistry/Pharmacy/Life sciences/Computer Sciences, or related field. Master degree preferred.

学士或以上学历，化学/制药/生命科学/计算机科学或相关领域。硕士学位优先考虑。

· Familiar with HPLC, GC, ICP-MS, LCMS, GCMS and other conventional chemical analysis instruments operation.

熟悉HPLC、GC、ICP-MS、LCMS、GCMS等常规化学分析仪器的操作

· Strong communication and presentation skills.

较强的沟通及表达能力。

· Collaborates well, while also can deal with conflict resolution

良好的合作能力，同时也有处理冲突的能力。

· Diligent with attention to detail

注重细节

· Proficiency in both spoken and written English. Good command of MS office software application

熟练掌握英语口语及书面表达，熟练应用微软办公软件

Understand related regulatory requirements and industry

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