Job ref no.: CT3116513-01#8498

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
  • 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

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