Johnson & Johnson Careers

DHR Clerk

Suzhou, Jiangsu
Quality Control


Job Description

Requisition ID: 1805654414W

  • 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