[Innovative Medicine] Sr. Supervisor, Operational Quality Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant)

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

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• 品質オペレーション G スーパーバイザーは製造に関わる業務について品質における全体的な 方向性を示す

法規制の順守に関する責任 Regulatory Compliance Responsibilities:

• 品質オペレーション Gスーパーバイザー は医薬品医療機器等の品質有効性及び安全性の確保等に 関する法律GMP/GCTP麻薬及び向精神薬取締法及びコーポレートポリシー手順に従う

主な職務及び主な責任 Major Job Duties and Responsibilities:

To support the operations from both direct and indirectly from the quality perspective in which the Quality Operations area based on training assigned the individual must:

• Promote and participate safety activities at site.

• Provide support and oversight to operations from product quality and compliance perspectives.

• Address issues being reported during manufacturing and support investigations of the operations team.

• Participate and support operations during regulatory inspections.

• Conduct regular meeting with sourcing sites on Kaizen activities and ensure the activities related to P2P meeting are completed on time and facilitate the P2P.

• Facilitate Kaizen activity in related processes.

• Support other quality functions process.

• Promote quality culture at site.

Quality & Compliance

• Carry out the assigned work in compliance with GMP/GCTP and Compliance regulations.

• Create modify and ensure updating of procedures and work instructions necessary for carrying out work activities.

• Complete the technical training assigned to the role and the related ones on time updates

• Support in training and enforcing compliance (such as DI) in the production area.

EHS

• Carry out the assigned work in compliance with the procedures and safety regulations.

• Promptly report to your supervisor all those situations that could endanger the health and safety of workers and / or the environment.

• Undergo information / training sessions and health surveillance provided for their job.

• See Johnson & Johnsons assets as a critical business asset which must be protected from theft loss destruction vandalism non-access authorized and malicious acts in general.

Computer & Automation Systems

• Correctly use the IT tools necessary to carry out the work activities.

• Comply with Johnsons Worldwide Information Asset Protection Policy & Johnson. Johnson & Johnson recognizes that information is a business asset crucial that they must be protected from unauthorized disclosure theft loss destruction unauthorized modification unauthorized access and denial of the availability.

職務の要件 Job Requirement

教育/経験 Education and Experiences:

• 薬学科学または工学の学位を修了していることが望ましい Degree in Pharmacy Science or Engineering is preferable.

知識資格及び技能 Knowledge Qualification and Skills:

• 品質システムに精通している Knowledgeable of quality system.

• Lean and Kaizen knowledge

• Statistical skills

行動特性 Core Competencies:

• コラボレーションチームワーク Collaboration and teamwork.

• 確固たるクレドーバリュー Credo value of integrity.

• 顧客重視 Customer focus.

• EHS手順に従う Comply with EHS rules and procedures at all times.

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Required Skills:

Preferred Skills: