[Innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing and Supply Div. (Fuji Plant)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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.

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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.

• GMP/GCTPにおける品質システムコンプライアンスの関わる業務を自ら実施しまたグループスタッフが担当する業務の監督を行う

• 法規制の順守に関する責任

• 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及びコーポレートポリシー手順に従う

• Perform tasks related to quality systems and compliance in GMP/GCTP and supervise the tasks handled by the group staff.

• Regulatory Compliance Responsibilities:

• Comply with Act on Securing Quality Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices GMP/GCTP all corporate policies and procedure.

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

• デー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

• 他グループメンバーが担当するGMP/GCTP活動業態管理などのサポート

• トラブルシューティング逸脱調査の準備

• 業務改善

• 新しい取り組みのリードもしくはサポート

• Manage GMP/GCTP activities such as Data Integrity Deviation management control Change control.

• Acting as the point of contact with the Marketing Authorization Holder including maintaining Quality Agreements implementing reporting requirements for deviations and related events and audit management.

• Support other group members GMP/GCTP activities and license management activities.

• Trouble shooting and investigation of deviation.

• Improvement initiatives

• Lead or support new initiatives.

職務の要件 Job Requirement

教育/経験Education and Experiences:

• 薬学理化学または生物学の学位を修了していることが望ましい Degree in Pharmacy physics and chemistry or biology is preferable.
• 製薬業界における品質管理品質保証規制遵守などの分野での5年以上の経験が望ましいMore than 5 years of experience in various areas such as Quality control Quality Assurance Regulatory Compliance in pharmaceutical industry is desirable.

知識資格及び技能 Knowledge Qualification and Skills:

• GMP/GQP/QMS品質システムに精通しているKnowledgeable of GMP/GQP/QMS quality systems.
• ビジネスレベルの英語力を有していることが望ましいBusiness-level English proficiency
• 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Trackwise
• Have an ability to effectively use software applications. Ex. MS office Trackwise

行動特性Core Competencies:

• リーダーシップ及びマネージメント力 Leadership and management skills
• コーチング Good coaching
• 問題解決能力 problem-solving skills
• チームワークコミュニケーションス及びコラボレーション能力 Excellent communication Collaboration and teamwork
• プロジェクトマネージメント力 Project Management skills
• 顧客フォーカス Customer focus

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