[Innovative Medicine] Staff, Quality Control Group, Quality Operations Dept., Manufacturing and Supp

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Supplier Quality

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 :

本従業員は、 GMP/GCTP および J&J 品質ガイドラインに準拠した ラボ品質システムの実装、改善および調和を実行する責任をもつ。

The employee is responsible for implementation, improvement and harmonization of laboratory quality systems in accordance with GMP/GCTP and J&J quality guidelines.

法規制の順守に関する責任 R egulatory Compliance R esponsibilities :

試験室の運用は、次の法律および規制に準拠している必要がある ( ただしこれらに限定されるものではな

い ) 。



* GMP/GCTP



* 麻薬および向精神薬管理法



* 日本薬局方などの公定書



* 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 ( 薬機法 )



* 毒物及び劇物取締法、有害物質規制法などの化学物質の法規制

Lab operations must be compliant with the following laws and regulations (but not limited to).



* GMP/GCTP



* Narcotics and Psychotropics Control Law



* Official compendium such as Japanese Pharmacopeia, etc.



* Pharmaceutical and Medical Device Act (PMD Act)



* Laws and regulations on Chemical Substances such as Poisonous and Deleterious



* Substances Control Law and the Hazardous Substances Control Law etc.

主な職務 及び責務 Major Job Dut i es and Responsibilities :



* ラボの品質システムの実装、改善、調和に責任を持つ。



* 他拠点と富士間での分析手法の移管をリ-ド?...