Job offer: Quality Management in Hikari with Takeda

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Job Description


  • Take ownership in the associated function as a Specialist
  • Drive collaboration in the function to proactively solve problems and continuously improve processes
  • Promote open culture to activate the teamwork


  • Prepare Quality Agreement for MH (Marketing Holder) / vender in a timely manner.
  • Conduct qualification process of new vender.
  • Keep the qualified venders status up to date.
  • Execute the required functional Quality Tasks to support KPI progress through performance dialogues
  • Encourage team members and themselves to get them motivated and committed
  • Develop and help talents be prepared for next functional lead position with multiple skills
  • Proactively involved in the identification and implementation of continuous improvement opportunities (AGILE)


Technical / Functional (Line) Expertise

  • Primary knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
  • Primary knowledge in API, solid dosage forms, parenteral technology, biologics or combination products.
  • Primary analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
  • Excellent verbal and written communication skills.
  • Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
  • Experience / expert with TrackWise Deviation / CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.


  • Primary leadership skills and demonstrated success in managing a team.
  • Primary interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, egender trust, influence key stakeholders, cooperate as a team lead, share information and deliver results with a team.
  • Lead and involve members for bottom-up suggestions through open dialogues

Decision-making and Autonomy

  • Primarily be able to deal with ambiguity, and make decisions under stressful conditions with manager’s support.
  • Sense of urgency.


  • Interacts with team members and relevant functions (Manufacturing, Engineering, Supply Chain, etc.)
  • Interacts with global Quality functions.
  • Share the best practices and expertise in / beyond the group


  • Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
  • Drive initiatives of “Quality Culture”, “AGILE 4.0”, “Digital” to drive continuous improvements.


  • Improve and conduct functional processes within / across the functions


  • High school diploma or higher diploma. Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline is preferred.
  • Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
  • Leadership and technical capabilities
  • Business level of English skill is preferred (both verbal and written)


Hikari, Japan

Worker Type


Worker Sub-Type


Time Type

Full time


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