Johnson & Johnson Careers

CLS Senior QC Engineer

Shanghai, China
Quality (Generalist)


Job Description

Requisition ID: 1805694470W

Coordinate the establishment, deployment and maintenance of XJP BQ QMS and processes in conformance to local regulations, corporate guidance/policies, and relevant international standards such as GSP, BQ SOP etc. Initiate appropriate actions to ensure high level system efficiency and effectiveness. Assume concretely for below included but not limited responsibilities:

     
  • Ensuring that appropriate processes and systems are in place at the respective 3PL DC’s the management of change which potential impact on 3PL QMS and the service provided to XJP as per contractual agreement with J&J。
  • Transportation service provider quality management at 3PL DC site.
  • Supplier of material (packing material) quality management at 3PL CLS DC site as need.
  • Equipment and facilities (J&J’s) quality management at 3PL CLS DC site as need.
  • Goods temperature/humidity control and transportation (storage, handling and disposition) quality management at 3PL CLS DC site.
  • CLS Ops routine quality management oversight.
  • Ensure that all required training is provided and managed appropriately for CLS Ops staff.
  • XJP BQ audit readiness support (JJRC and local CFDA inspection)
  • Compliance with XJP quality documents system.
  • Identifying, coordinating and presenting appropriate metrics related to DC Q&C metrics as part of the XJP BQ LOC QSMR, including progress against deliverables, and programmes for continuous improvement of 3PL QMS at DC level
  • Ensuring concerns regarding product quality, safety or compliance related to DC activities are reported to the supervisor/BQ head so he/she can determine based on information provided whether escalation per STA-1002 is necessary
  • Ensuring appropriate oversight of distribution complaints in alignment with XJP QMS procedure.
  • Support new product launch readiness in close collaborate with XJP BQ.
  • Partner with other functions on timely issue management to enable undisrupted supply of products in a compliant way.
  • Support BQ on JJRC develop mitigation plan based on Qscan result as need. 
  • Proactive implementation of new/revised HA regulations and J&J Standards significant new regulations in close collaboration with cross functional stakeholders
  • Provide effective input on laws and regulations as needed or required
  • As per other assignments by direct supervisor if necessary 


Qualifications
  • Bachelor and/or above degree (better in pharmacy, medicine, biochemistry, logistics, management and other related professional);本科 及以上学历,药学、医学、生物化学、物流,、管理等相关专业
  • At least 3 years working experience in pharmaceutical/medical device/cosmetics wholesale enterprise in charge of the quality compliance related management 至少3年以上从事药品/医疗器械/快消企业质量合规管理相关工作经验
  • Customer Focus(Results and Performance Driven,Sense of Urgency)注重客户需求,以结果和绩效为导向,具备前瞻和危机意识;
  • Innovative Solutions(Strategic Thinking,Big Picture Orientation with Attention to Detail),Intellectual Curiosity,Prudent Risk-Taking;具备创新解决问题的思路和策略性思维,兼顾宏观和微观意识,进取心强,处事谨慎;
  • Collaboration and Teaming,Self-awareness and Adaptability擅于团队合作,自我改变及适应性强
  • Good communication skill 良好的沟通技巧
  • Good command of English in writing and speaking 良好的英语听说读写能力
  • Strong knowledge of GMP/GDP/GWP/GSP, ISO, J&J standards and other quality systems and guidelines of cross sectors. 具备良好的GMP/GDP/GSP/GWP,ISO强生标准和其他跨事业部门的质量体系及指导的知识
  • Local RA requirement, Temperature control/ purchasing control  本地法规的要求; 温度控制/采购控制
  • Better to have - Licensed pharmacist qualification有执业药师资格更好

Primary Location
China-Shanghai-Shanghai-Building A, Xinyan Mansion, No. 65, Guiqing Rd., Xuhui District, Shanghai
Organization
Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function
Quality (Generalist)
Requisition ID
1805694470W