Quality Document Clerk

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Documentation

Job Category:
Business Enablement/Support

All Job Posting Locations:
Suzhou, Jiangsu, China

Job Description:

Perform the principal duties of quality document clerk: 完成质量文件管理员的主要职责； ▪ Responsible for management, issuing and filing of internal and external documents; 负责管理、分发和保存内部及外来的文件； ▪ Responsible for control, retention and destruction of quality records; 负责质量记录的控制、保存和销毁； ▪ Responsible for purchasing and collection of external documents timely; 负责及时地采购和收集外来文件； ▪ Responsible of creating and modification of work instruction related to document control; 负责创建和修改与文件控制相关的工作指导书； ▪ Responsible for coordination of periodical review of documents.

负责协调文件的周期评审； ▪ Responsible for the trainings related with document management (if needed).

负责文件管理相关的培训（如需要）。 ▪ Other duties assigned by supervisor according to business requirement: 根据业务需要，由主管指派的其他职责：

Support the development and implementation of electronic systems related to document management or other duties.

支持与文件管理相关的电子系统开发和执行，或其他职责。 ▪ In accordance with DePuy Synthes Worldwide Quality strategy, participate in the development of the quality system and its day to day implementation: 按照 DePuy Synthes 全球质量战略，参与质量体系的发展及其日常实施： ▪ Participate in training to workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 13485 and NMPA requirements.

基于 FDA QSR, ISO 13485 和 NMPA 要求，参与车间员工的培训和现场质量管理； ▪ Ensure compliance to all GMPs requirements.

确保遵守所有的生产质量管理规范要求； ▪ Conduct internal quality audits as required.

按要求执行内部质量审核。 ▪ Perform all job duties in full accordance with: 执行所有工作职责完全按照： ▪ The J&J policies on Information, Assets protection, maintain password(s) confidential, protect critical Business Information.

信息、资产保护、维护密码、保护关键业务信息的强生公司政策； ▪ All J&J policies and local regulations.

强生公司所有的政策和地方性法规； ▪ The policies of the Health Care and Environmental programs.

卫生保健和环境规划的政策； ▪ The code of conduct policies.

行为守则政策。 ▪ Full responsibility and ownership (like all employees on site) for all audits support (including internal, Corporate, External, for Quality, H&S, Environment, etc.).

全权负责（和现场所有员工一样）所有的审核支持（包括质量相关的内审、总部审核、外审以 及环境、健康和安全相关的审核等）。