J&J Family of Companies DHR Clerk in Suzhou, China

  • Responsible for routine Device History Records (DHR) review. During DHR review, if any deviation is found, return to originator for correction/负责DHR审核,将发现的DHR错误退回先关人员更改。

  • Ensure the completed DHR meet all GMP/ MDD requirements after review /确保审核完成的DHR符合GMP/MDD的要求。

  • Ensure product is released properly and timely after DHR review, and issue certificate of conformance if required/确保产品审核后放行准确和及时,并出具产品合格证书。

  • Perform final inspection activities for China market products as per CFDA requirements/应CFDA的要求完成中国市场产品的出厂检验

  • Responsible for trends analysis for failure mode of DHR review result. /负责 DHR审核结果的失效模式分析。

  • Responsible for the timely filing of the completed DHRs. / 负责定期完成DHR的存档。

  • Work closely with Quality engineering, QA and operation to finish DHR error evaluation and affected product disposition in time/与QE,QA,生产密切工作,完成DHR错误的评估和及时处置产品。

  • Perform GMP audit on cells to improve the compliance. /对生产进行GMP审核以改善符合性。

  • Perform DHR training on cells to improve the DHR correctness. /对生产人员进行DHR培训以改善DHR的正确性。

  • Support other team for the improvement activities. /支持其他团队的改善活动。

  • Assist in the developing and improving performance measures/ 辅助改进绩效测量

  • Assurance team achieve the operation and quality target / 确保团队达到运营和质量目标;

  • As a guide, take initiative activities base on the needs from both internal or external customer in daily work./ 作为一个指导,在日常工作中根据内外部客户的需求采取主动性行动。

  • Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…)./ 与其他所有员工一样,对所有审核 (内部,公司,外部的质量,环境,健康安全) 负责。

  • Perform all job duties in full accordance with: / 完成所有工作职责时参照:

  • The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information; / 强生关于信息,资产保护,维护密码保密性,保护关键业务信息的政策;

  • All J&J policies and regulations; / 所有强生政策和规定;

  • The policies of the Health Care and Environmental programs; / 卫生保健和环境程序的政策;

  • The code of conduct policies; / 行为准则政策;

  • Perform other work assigned by supervisor; / 执行主管分配的其它工作;

Qualifications

  • Teamwork and communication skill, self-inspiring ability / 团队工作和沟通技能, 自我激励

  • Continuous and versatile learning ability/持续学习能力

  • Good GMP knowledge and ISO13485 quality system or equivalent training /良好的GMP和ISO13485质量体系知识或等同的培训

  • Computer literacy skill/熟练使用电脑

  • Written and verbal English skill/会书写和口头英语表达能力

  • University degree or above,major in Mechanical or Pharmaceutics or equivalent training /大学或以上学历, 机械或药学专业或等同的培训

  • 2 years or above working experiences related to quality or inspection in medical devices/Pharmaceutical plant/2年及以上医疗器械或药品质量或检验工作经验

  • Simple Statistics简单的数据统记,分析

  • Basic audit skill. / 基本的审核技巧

  • Sense of urgency & efficiency / 紧急性和效率的观念

  • Ability to Work under pressure; / 压力之下工作的能力

Primary Location

China-Jiangsu-Suzhou

Organization

Johnson & Johnson Medical Suzhou Ltd. (7054)

Job Function

Quality Control

Requisition ID

1805654414W