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Healthcare Coordinator

Healthcare Coordinator

Tokyo, Japan

 

Main Responsibilities

  • Lead Quality Management System - both local regulation and company requirements. 
  • Maintain all legally required record and documents. Lead local authority/certified third party audit.
  • Perform/Support Risk Assessment.
  • Lead and tracking of self inspection.
  • Maintain Quality Agreements with EMO/DC/EMB and other Intercompany. Including update based on local regulation and company requirements.
  • Create and implement SOPs and controls to consistently meet what is defined in dossiers and or registered 
  • Plan and Lead EMO, Embellisher,WH, authority and NB audits, report the status to region.
  • Documentation of EMO/EMB release COA.
  • Actively participates in company wide projects that impact controlled documentation and provide facilitation to the project members to ensure timely completion of these documents.

 

Knowledge /Competences

  • Intermediate level English and Native level of  Japanese.
  • Knowledge of Japanese legal regulations and industrial standards such as GQP/QMS/GDP.
  • Knowledge of the high Quality standard of Japan market.
  • Knowledge of legislation, regulations and standards at Japan market.
  • Proven track record to manage multiple multi-functional projects.
  • Track record of delivery, goal oriented, sets clear priorities and meets deadlines.
  • Has a positive and motivating influence, sets good examples.
  • Results oriented, entrepreneurial and self-motivating.
  • Good planning and organizational ability.
  •  Ambitious and flexible. Capable of working independently.
  • High level of interpersonal communication ability.
  • Analytical skills: ability to define problems, collect details data, analyze and interpret results and recommend changes and improvements.

 

Experience:

  • QC and manufacturing preferably in FMCG or Pharmaceutical industry.
  • Background of chemistry is a plus.
  • Pharmacist license holder is preferable.

 

Education:

  • Degree: Bachelors  or equivalent
  • Major preferred: Scientific field preferably in Pharmaceutical science

 

 

 


Job Segment: Medical, Healthcare

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