[Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing an

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:
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

職務概要 Position Summary:

本職務記述書は、品質システムGに適用する。This Job Description applies to the position of Quality System Group at JPKK, Fuji Plant.


* 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及びコ-ポレ-トポリシ-、手順に従い、与えられた品質システム、コンプライアンスの関わる業務を実施する。

In accordance with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc., GMP/GCTP regulations, and corporate policies and procedures, perform assigned quality system- and compliance-related activities.

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


* デ-タインテグリティの遵守•推進、逸脱管理、変更管理などのGMP/GCTP活動


* 製造販売業者との窓口として品質取決めの維持、逸脱などの報告要件の実施、査察の対応


* 他グル-プメンバ-が担当するGMP/GCTP活動、業態管理などのサポ-ト


* トラブルシュ-ティング、逸脱調査の準備


* 業務改善


* 新しい取り組みのリ-ドもし