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Program Manager (FDA products)

Bring In Technology Limited

  • Company Industries:Management Consultancy / Service

Job Information

  • Post Date:2016-11-07
  • Location:Not Specified
  • Salary:Salary negotiable
  • Employment Type:Full Time, Permanent
  • Job Function:Manufacturing & Production  Manufacturing Management  Others  
  • Benefits:Five-day work week  Medical insurance

Job Description

Responsibilities 

  • Work directly and closely with different function with factory including manufacturing, purchasing, quality, logistics and supply chain, etc. to make sure facilities, processes and products are executed per the documented approaches (FDA compiled)
  • To create and maintain factory performance monitoring framework in Quality, Productivity, Delivery Performance, New Product Introduction areas.
  • Manage competing priorities to ensure targets and timelines are met.
  • Ensure changes have the appropriate level of technical assessment, control, and approval.
  • In co-ordination with the Compliance Manager, Plan and conduct periodical audit to identify compliance and improvement areas.
  • Ability to interpret and relate quality standards for implementation and review.
  • Map production constraints and monitor supplier production and delivery performance to ensure agreed output are achieved with right quality.
  • Ability to communicate clearly and professionally both in writing and verbally in both Mandarin and English.
  • Ability to work independently and cross-functionally in a dynamic environment.
  • Robust understanding of CAP and NC protocols, standard practices, and root cause analysis investigation techniques.
  • Flexibility in problem solving, providing direction and work hours to meet business objectives.

 Requirements:

  • Degree holder science and/or engineering related, and at least 3 years of experience in the pharmaceutical or bio-pharmaceutical industry, or an equivalent combination of education and experience (or medical device experiences can be considered)
  • Superior English skills is a “must have”.
  • Experience with ISO13485 and/or related standards are added advantage
  • Prior experience using some form of ERP management software system would be preferred
  • Need to station in Shenzhen to work closely with supplier's production site

 

We offer competitive remuneration package, 5-day work and medical insurance to the successful candidate. Interested parties, please send your Resume with expected salary. 

Personal data will be used for recruitment purpose only.

Company Info

We focus in Consumer Electronics Supply Chain Management Service to overseas clients. We provide ODM and OEM service to customers. We are a profession team with in-house technical resources and test facilities to evaluate product development from design, prototyping till mass production stages. To cope with our operation expansion, we are looking for the candidates to support our business growth.

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