[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

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の実現をする。
This individual implements the quality perspective direction 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、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(Beerse) 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...