[Innovative Medicine] Supervisor, Quality System 1 Group, Quality Operations Dept., Manufacturing an

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Systems

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 https://www.jnj.com/innovative-medicine

職務概要 Position Summary:


* 本職務記述書は、品質システムGに適用する。This Job Description applies to the position of Quality System Group at JPKK, Fuji Plant.


* GMP/GCTPにおける品質システム、コンプライアンスの関わる業務を自ら実施し、また、グループスタッフが担当する業務の監督を行う。Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group staff.

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


* 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及びコーポレートポリシー、手順に従う。Comply with Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP, all corporate policies and procedure.

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


* GMP遵守のため、アサインされた各種トレーニングをチーム内のスタッフ全員が期日通りに完了できるようにサポートする。Support all team members in completing assigned training on time to ensure GMP compliance.


* グループスタッフが担当するGMP/GCTP活動、業態管理などの監督 Supervise group staff's GMP/GCTP activities, business format management, etc.


* 作業逸脱、品質問題が起こった場合の根本原因、アクションプランの策定に関し、チーム内の各スタッフをサポートする。Support team members in identifying root causes and developing action plans for operational deviations and quality issues.


* JJRC、外部GMP査察等に対応し、指摘事項に関する継続的な改善をチームの一員として積極的に行う。Respond to JJRC and e...