[Innovative Medicine] Quality Control Group Analyst, Quality Operations Dept., Fuji Plant, Manufactu

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:
Professional

All Job Posting Locations:
Shizuoka, Japan

Job Description:

About Johnson & Johnson

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/.  



* Responsible for implementation, improvement and harmonization of laboratory quality systems.


* Responsible for ensuring all laboratory systems comply with GMP/GCTP and J&J guidelines and quality standards, including support to regulatory filings and sub-system owner for laboratory systems.


* Perform the activities, encompassing activities in support of laboratory systems, e.g.

equipment qualification, compendia and quality standard review, stability program administration, analytical change control, LIMS, Empower, training, etc.


* Leads and supports projects within laboratories aimed at improving on financial targets, efficiencies and productivities achieving increasing agility and flow throughput, reducing cost, cycle time, inventory reduction, performance improvement and error reduction.


* Ensures required GMP/GCTP, EHS and role-related training required to work safely and in compliance with regulatory requirements and as defined by their training matrix.


* Proactively supports GMP/GCTP compliance, permanent audit readiness, identification of compliance risks and breaches.


* Any other duties as assigned by the Quality Control Manager or Lab Lead.



* 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 オーナーへのサポートも含まれる。


* 試験室システムを支援する活動を実施する。機器の適格性評価、公定書および品質基準のレビュー、安定性試é¨...