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

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 . 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 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及びコーポレートポリシー、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 Leadership 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 #LI-Onsite ======================================================== 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: Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards