Job ref no.: CT3116513-01#0718

Operation Manager (FDA Products)

AMAC Human Resources Consultants

Negotiable Per Month

Operation Manager (FDA products)
  • Degree holder in Engineering or related discipline
  • At least 3 years of experience in the medical device or pharmaceutical industry, or an equivalent combination of education and experience
  • Prior actual FDA audit experiences would be preferred
  • Excellent English and Mandarin skill is a must
  • Robust understanding of CAPA and NC protocols, standard practices, and root cause analysis investigation techniques
  • Ability to work independently and cross-functionally in a dynamic environment
  • Flexibility in problem solving, providing direction and work hours to meet business objectives
  • Need to station in Southern China to work closely with supplier's production site
Job Duties:
  • Work directly and closely with supplier's different functions on site including manufacturing, purchasing, quality, logistics and supply chain, etc. to make sure facilities, processes and products (FDA listed) are executed per the documented approaches
  • To monitor supplier's overall performance in area of Production Capacity, Productivity, Delivery Performance and New Product Introduction areas
  • Ability to make sound direction and decision relate to GMP traceability, production engineering, quality improvements for FDA regulated products.
  • To review, validate and optimized supplier's production process
  • Manage competing priorities to ensure targets and timelines are met
  • Ensure process / component changes as requested by suppliers have the appropriate level of technical assessment, control, and approval 
  • In co-ordination with the Quality Manager, plan and conduct periodical audit to identify process gaps and improvement areas
  • Map production constraints and monitor supplier production and delivery performance to ensure agreed output are achieved with right quality
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More job information
Job ref no. CT3116513-01#0718
  • N/A
Job Function
  • 3 years - 8 years
Career Level
  • Non-management level
  • Degree