仕事内容＜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 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.
＜Business Title: Sr. Manager-SQC＞
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
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
勤務地
想定年収
福利厚生・待遇
勤務条件【勤務時間】8：45～17：30
【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。
(ただし、一斉休憩を除く)1日の必要最低労働時間：4時間(半日休暇時は2時間)
一斉休憩：12時～13時
完全週休2日制（土・日曜日）、祝日、クリスマス、年末年始・夏期※年間休日125日 年次有給休暇、慶弔等
6か月間
試用期間中での賃金の違いはありません。
昇給年1回、賞与年3回
保険（雇用・労災・健康・厚生年金保険）
Recruiting No.
社名
事業内容
【東証プライム上場 産業機器、ポンプ、航空、医療分野等の専門精密機器メーカー】 メディカル事業本部 カスタマーサービスグループ 品質保証担当
【総合電機メーカー直系の老舗コンサルティング会社】 業務改革・事業変革のコンサルタント
【東証プライム上場 総合商社】 モビリティ領域 車載電池の資源循環における事業開発
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