仕事内容品質保証本部にて理化学試験のLeader(責任者)をお願いします。
職務内容
<職務/Job Responsibilities>
This position is responsible for the management of his/her team and has the following principal
accountabilities as an area supervision/technical resource/technical Subject Matter Expert (SME).
・Manage the quality system of analysis for semi-finished products and final products.
・Build the quality system based on the Global Audit, Site Quality plan, and GQS/LQS requirements.
・Extend Japanese high quality level to the other sites by effective communication.
・Manage team staff and support to get the opportunities to increase the advanced skill and the
GMP knowledge.
・Certify team members to perform each role.
・Review and approve QC testing/inspection results, deviations, changes, Analytical
Investigation report for invalidated OOS/OOT per procedure.
・Review and approve QC technical documents as appropriate.
Safety, Quality, Compliance&Service
・Always pay attention to and proactively participate the Health, Safety and Environment (HSE)
related activities in order to achieve zero serious incident and fatality.
・Provide guidance and consultation to others for HSE improvement.
・Manage and control overall system of analytical test for semi-finished products and final
products.
・Understand the GMP/QMS and the Pharmaceutical Affairs Law, and educate the subordinates to
handle in an appropriate manner.
・Gain sufficient technical/transferable skill, provide solutions for technical problems and
operational support to team members.
・Process&Operational Excellence
・Serve as QC Process Team Leader to ensure safety, quality, capacity and execution excellence.
・Communicate with global/local counterparts to solve problems and enhance Operational
Excellence.
・Lead projects for compliance, efficiency, operational excellence and/or optimization. (e.g., lean,
global/local projects, lab equipment recapitalization, new products launch preparation)
・Make sure all required activities are planned and executed, such as equipment periodic
maintenance or stability program.
・Maintain the validated state of analytical method and equipment following method transfer
and/or equipment qualification.
・Identify and implement process improvements to continually enhance the quality of the
operations, workflow, and procedures.
People, Organization&Others
・Communicate with team members periodically to work properly, and provide appropriate
supports and opportunities for team members' development and career planning. (One-on-One /
Performance Management /Development plan etc.)
・Develop staffs that have the technical/transferable skill and confirm the training records.
・Reexamine and adjust human resource/equipment capacity periodically to build more
systematic and more highly qualified team.
・As QC Lead Team member, develop and implement strategic plan, manage and control
team expense and resource.
経験・資格<必須経験Mandatory requirements/スキル・資格Skill/Certification>
・Bachelor’s degree in a scientific area or health care field
・Experience in the pharmaceutical QC labs under GMP/GQP and
Pharmaceutical Business Law or equivalent
・Knowledge/Experience of analytical testing (Chemical and/or Micro-biological and/or Biological
testing), analytical method transfer, and lab equipment
・Work experience under global environment
・Strong oral and written communication skills in Japanese and English (Japanese: Native level,
English: Business level (TOEIC>850, Versant score>52))
・Strong self-management and organizational skills; able to manage multiple priorities and
appropriately network across a wide variety of functional components and business partners
・Strong interpersonal and collaborative work style, including the ability to provide leadership and
promote teamwork among individuals with diverse style
・Strong ability of people management, operation management, project management, problem
solving, influence others and stakeholders without direct positional authority
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Recruiting No.
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事業内容
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