[Innovative Medicine] Analyst, Operational Quality 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 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 https://www.jnj.com/innovative-medicine

Position Summary:


* この職務内容はヤンセンファーマ富士工場の品質オペレーショングループスタッフのポジションに適用される。 (This Job Description applies to the position of Operational Quality Group Staff at JPKK, Fuji Plant.)


* 品質オペレーションG メンバーは、苦情処理及びAPR/PQR の責任者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。(This individual provides quality perspective direction for all complaint handling and APR/PQR activities at JPKK, Fuji Plant).


* 組織の製品に関わるプロセスや業務の文書をレビューする。(Reviews documentation associated with processes and activities for the organization's products).


* 品質管理システムの継続的な改善のため、日常的なデータ収集と報告を維持する。(Helps maintain routine data collection and reporting to ensure the continuous improvement of the quality management system).

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, 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, Narcotics and Psychotropics Control Law all corporate and site policies and procedure).

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

割り当てられたトレーニングに基づき、上司の監督の下、オペレーションエリアでの主要な職務を遂行するために、個人は以下のことをè¡...