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

Fuji - Japan

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Shizuoka Japan

Job Description:

About Innovative Medicine

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.

Learn more at Position Summary:

品質オペレーション G スタッフは品質オペレーショングループが示した品質における全体的な方向性実現のため行動する
This individual implements the quality perspective direction which Operational Quality provides for all production activities at JPKK Fuji.

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 スタッフ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省令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
Operational Quality Group Staff will comply with the Act on Securing Quality Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices GMP/GCTP ordinance Narcotics and Psychotropics Control Law all corporate and site policies and procedures.

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

品質の視点から当社の生産オペレーションを直接的間接的にサポートいただきます割り当てられた教育に基づき現場の安全性と製品品質の両立を図りつつ改善活動や規制対応をリードします

サイトにおける安全活動の推進および参加
製品品質およびコンプライアンスの観点からオペレーションへの支援監督
生産中に報告された問題への対応とオペレーションチームの調査支援
品質オペレーションG内品質部門内他部署のプロセス支援
規制当局による査察時のオペレーション支援
関連プロセスにおける改善活動のファシリテーション
サイト全体の品質文化の醸成啓発

品質コンプライアンス

GMP/GCTP省令および社内コンプライアンス規程に従い割り当てられた業務を遂行する
業務遂行に必要な手順書や作業指示書を作成改訂し最新版へ更新されるよう管理する
役割に割り当てられた技術研修および関連研修を期限内に修了し必要な更新対応を行う
製造現場におけるコンプライアンス例Data Integrityの教育順守支援および徹底に協力する

EHS

手順書および安全規程に従い割り当てられた業務を遂行する
作業者の健康安全や環境を脅かす可能性のある事象は速やかに上司へ報告する
業務で定められた情報提供研修を受講し必要な健康管理健康診断等を受ける

コンピュータ自動化

業務遂行に必要なITツールを適切に使用する
Johnson & Johnsonのワールドワイド情報資産保護ポリシーを遵守するJohnson & Johnsonは情報を事業上重要な資産と認識しており不正開示盗難紛失破壊不正な改ざん不正アクセス可用性の喪失などから保護する必要がある

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 in safety activities at site.
Provide support and oversight into operations from product quality and compliance perspectives.
Address issues being reported during manufacturing and support investigations of the operations team.
Support other process inside operational quality group and/or other quality functions process.
Participate and support operations during regulatory inspections.
Facilitate Kaizen activity in related processes.
Promote quality culture at site.

Quality & Compliance

Carry out the assigned work in compliance with GMP/GCTP ordinance 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 Data Integrity) 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.

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 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

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.
リーンおよび改善の知識Lean and Kaizen knowledge
統計のスキルStatistical skills
ビジネス会話レベルの英語と日本語 Business-level English and Japanese

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ルール手順に従う Comply with EHS rules and procedures at all times.
インシデントニアミス等の報告 Report all incidents accidents and near miss events.

#LI-Onsite

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Required Skills:

Preferred Skills:

Analytical Reasoning Business Behavior Compliance Management Detail-Oriented Execution Focus Goal Attainment Human-Centered Design Internal Controls Process Oriented Quality Assurance (QA) Quality Control (QC) Quality Management Systems (QMS) Quality Processes Quality Standards

Required Experience: