Manager or Staff, Quality Systems & Compliance, Osaka Site

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

This job requires native level Japanese proficiency in writing reading and speaking.

OBJECTIVES/PURPOSE

• Lead and manage the associated function as a Lead Specialist on QS&C
• Drive collaboration across the group/department to proactively solve problems and continuously improve processes
• Develop talents and promote open culture to activate the teamwork

ACCOUNTABILITIES

• Lead and manage QS&C activities assigned from the below and specified in GMP Job Description
  • Responsible for construction and maintenance of document structure of the Site.
  • Responsible for owning explaining and training of Process for Good Documentation Practice
  • Responsible for preparing of annual GMP training plan.
  • Develop Improve and explain Learning management system.
  • Supervise training coordinators of each department.
  • Introduce innovative training methodologies at the site
  • Business Process Owner for Complaint Handling related SOPs
  • Manage inspection readiness handling and follow up
  • Lead preparation of PQRs and review of PQRs
  • Manage preparation of regulation documents in a timely manner
  • Responsible for review of assessment and action plan in change control system.
  • Manage and handle change control for timely completion.
  • Explain and train change control system as business process owner.
  • Responsible for review of Validation master plan protocol and report.
  • Explain and train Validation as business process owner.
  • Manage and promote Data integrity.
  • Manage and prepare Quality Agreement for MH / vender in a timely manner.
  • Manage qualification process of new vender.
  • Manage qualified venders to keep the status up to date.
• Lead and involve team members with priorities action plans expected roles and schedules to get them motivated and committed
• Develop and help talents be prepared for next functional lead position with multiple skills
• Assists/Involved/Lead in the identification and implementation of continuous improvement opportunities (AGILE)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Primary knowledge of the local and international regulatory regulations including GMP ICH other related guidelines.
• Primary knowledge in parenteral technology cell therapy or combination products.
• Strong 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/expertise with TrackWise Deviation/CAPA and SAP preferred.

Leadership

• Primary leadership skills and demonstrated success in managing a team.
• Primary interpersonal skills including ability to build authentic relationships constructively challenge conventional thinking engender 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 managers support.
• Sense of urgency.

Interaction

• Interacts with team members and relevant functions (Quality Control Manufacturing Engineering Supply Chain etc.)
• Interacts with global Quality functions.
• Interacts frequently with functional peers and the Quality Leadership Team.
• Share the best practices and expertise in / beyond the group

Innovation

• 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.

Complexity

• Improve and conduct functional processes within/across the functions

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree or higher (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 people management and technical capabilities
• Business level of English skill is preferred (both verbal and written)
• Manufacturing knowledge for the product territory which this job covered.

ADDITIONAL INFORMATION

This job description is not designed to be a complete list of all duties and responsibilities required of this job

募集部門の紹介

品質システムズコンプライアンスグループは患者様へ届ける医薬品の製造管理及び試験検査を監督しその品質が確かなものであることを保証するシステム仕組みを構築推進するとともに国内外の規制当局による査察への対応等コンプライアンスの維持管理を担っています

大阪工場で生産する無菌注射剤は日本国内にとどまらずグローバルに出荷される医薬品のため関連するグローバルプロジェクトバリデーションデータインテグリティ無菌関連などにも積極的に関与しプロジェクトをリードしています

タケダを代表する製剤の製造品質を強固なものとする取り組みを一緒に加速していただける方を求めています

職務内容

無菌注射剤の品質保証GMPに関わる業務全般

具体的には

• 品質イベントの管理逸脱CAPA苦情
• 品質システムの継続的改善に向けた取り組みの推進リスクレジスター
• バリデーションプログラムの管理
• 自己点検製品品質照査文書管理教育訓練等の品質保証業務
• 原材料サプライヤー管理
• 国内外の当局査察や顧客による監査への対応

上記業務のいずれかにてリーダーとしての経験を積んでいただきます

応募要件

学歴

大学卒業以上

化学薬学工学生物学または関連分野の学士号を有していれば望ましい

実務経験/スキル必須

医薬品の品質保証品質管理製造に関するGMP業務経験および知識

国内外の査察対応当局製造販売承認に関わる業務の経験

PIC/sや三極など当局規制に関する知識

リーダーシップ力コミュニケーション力グループ内だけでなくクロスファンクショナルに業務対応できるスキル

実務経験/スキル歓迎

無菌製剤に関する品質保証の業務経験および知識

語学

ビジネスレベルの英語力

会話文章ともに業務上遂行できるレベルが望ましい

保有資格

薬剤師免許保有者は歓迎します

求める人物像

Global Qualityとの連携の中でBest Practiceをプロアクティブに追求する意欲をもち新しいアプローチを提案できる方

科学的な考察により理論構築できる方

Takeda Compensation and Benefits Summary:

• Allowances: Commutation Housing Overtime Work etc.

• Salary Increase: Annually Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30 Production Sites (Osaka/ Yamaguchi) 8:00-16:45 (Narita) 8:30-17:15 Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays Sundays National Holidays May Day Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave Special Paid Leave Sick Leave Family Support Leave Maternity Leave Childcare Leave Family Nursing Leave.

• Flexible Work Styles: Flextime Telework

• Benefits: Social Insurance Retirement and Corporate Pension Employee Stock Ownership Program etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the companys discretion.

• It is possible the department and workplace may change at the companys discretion.

Locations

Worker Type

Worker Sub-Type

Time Type