＜品質保証部＞西神品質管理 Seishin QC/課長 Sr. Manager /西神工場（神戸市内）

【求人No NJB2310045】
【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 Seishin QC testing/inspection results deviations changes Analytical Investigation report for invalidated OOS/OOT per procedure.
・Review and approve Seishin 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 Seishin QC Lead Team member develop and implement strategic plan manage and control team expense and resource.

＜必須経験 Mandatory requirements/スキル・資格 Skill/Certification＞
・Bachelor’s degree in a scientific area or health care field
・Minimum of 5+ years of 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
・5+ years 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