[Innovative Medicine] Operational Quality Supervisor (Night Shift), Operational Quality Group, Quali

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:
Supplier Quality

Job Category:
People Leader

All Job Posting Locations:
Sunto, 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、品質オペレーション G スーパーバイザーに適用する。 This Job Description applies to the position of Operational Quality Group Supervisor at JPKK, Fuji Plant.


* 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。 This individual provides quality perspective direction for all production activities at JPKK, Fuji Plant.

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。


* Operational Quality Group Supervisor will comply with 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:

Quality Operations Support Activities:

To effectively support both direct and indirect operations from a quality perspective within the Quality Operations area, the individual must perform the following activities based on assigned training:

Night Shift Responsibilities:


* Operational Support:
+ Assist the Operational Quality Group staff in their daily activities during the night shift, ensuring continuous quality oversight.


* Routine Rounds:
+ Collaborate with night shift staff to conduct routine rounds, ensuring Good Manufacturing Practices (GMP), compliance, and safety standards are consistently met in all GMP areas.


* Incide...