[Innovative Medicine] Senior Assistant, Quality Systems, Quality Control Group, Quality Operations D

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:
Business Enablement/Support

All Job Posting Locations:
Shizuoka, Japan

Job Description:

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/.

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 Regulatory Compliance Responsibilities:

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.

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


* ラボの品質システムの実装、改善、調和に責任を持つ。


* すべてのラボ システムが GMP/GCTP および J&J ガイドラインおよび品質基準に準拠していることを確認する責任がある。これには、ラボ システムの規制当局への提出やサブシステム オーナーへのサ...