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 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:
QualityJob Sub Function:
Supplier QualityJob Category:
ProfessionalAll Job Posting Locations:
Shizuoka, JapanJob 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
- 本職務記述書は、品質システムGに適用する。
- GMP/GCTPにおける品質システム、規制物質におけるコンプライアンス業務を自ら実施する。
主な職務及び主な責任
- 規制物質に関わる責任者として、工場で行われる業務の監督、帳簿の作成、法令に定められている書類の作成及び当局への提出、定例会議の開催、担当する業の管理、調査の対応などを行う。
- 承認書との整合性確認のプロセスオーナーとして運営、資料作成、評価を行う。
- 当該製造所が保有する各種業の変更届等の作成を行う。
- 回収などのGMP責任者としてプロセスの運営を行う。
- 新しい取り組みをスーパーバイザーのサポートのもと実行する。
教育/経験
- 以下のいずれかに該当する者
- 大学で薬学または化学を修了
- 高校で化学の専門科目を修めて卒業し、向精神薬を扱った製造等の経験が4年以上ある
- 向精神薬を扱った製造等の経験が7年以上ある
- 製薬業界におけるGMP分野での経験が4年以上あることが望ましい。
知識、資格、及び技能
- 医薬品工場での製造または品質に関する知識・経験
- GMP/GQP/QMS品質システムに関する知識・経験
- ビジネスレベルの英語力を有していること（尚可）
- ソフトウエアアプリケーションを効果的に使用できる能力を有していること。例: MSオフィス
行動特性
- チームワーク
- コミュニケーション力
- 問題解決能力
- 学ぶ姿勢
- 正確な作業
Position Summary:
・This Job Description applies to the position of Quality System Group at JPKK, Fuji Plant.
・Perform tasks related to quality systems in GMP/GCTP and tasks related to Controlled substances compliance.
Major Job Duties and Responsibilities
- Serve as the responsible person for regulated substances, overseeing operations conducted at the manufacturing site, maintaining records, preparing legally required documentation and submitting them to authorities, organizing regular meetings, managing assigned business activities, and handling inspections/investigations.
- Act as the process owner for ensuring alignment with regulatory approvals, managing the process, preparing documentation, and conducting assessments.
- Prepare and submit notifications of changes related to licenses and business categories held by the manufacturing site.
- Operate and manage recall processes as the GMP responsible person, ensuring compliance with applicable requirements.
- Execute new initiatives under the supervision and support of the supervisor.
Education / Experience
Candidates must meet at least one of the following criteria:
- A degree in Pharmacy or Chemistry from a university
- Graduation from high school with a specialization in Chemistry, and minimum 4 years of experience in manufacturing or handling psychotropic substances
- Minimum 7 years of experience in manufacturing or handling psychotropic substances
- Preferably, minimum 4 years of experience in the GMP field within the pharmaceutical industry
Knowledge, Qualifications, and Skills
- Knowledge and experience in manufacturing or quality operations in a pharmaceutical facility
- Knowledge and experience in GMP, GQP, and QMS quality systems
- Business-level English proficiency (preferred)
- Ability to effectively use software applications (e.g., Microsoft Office)
Competencies (Behavioral)
- Teamwork
- Communication skills
- Problem-solving ability
- Willingness to learn
- Accuracy in work execution
#LI-Onsite
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社内公募ガイドライン
応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Execution Focus, ISO 9001, Issue Escalation, Performance Monitoring, Persistence and Tenacity, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection