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:** 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 品質オペレーション G スタッフは、品質オペレーショングループが示した品質における全体的な方向性の実現をする。 _This individual implements the quality perspective direction for all production activities at JPKK, Fuji._ **法規制の順守に関する責任 / Regulatory Compliance Responsibilities:** + 品質オペレーション G スタッフは、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、麻薬及び向精神薬取締法及びコーポレートポリシー、手順に従う。 **主な職務及び主な責任 / Major Job Duties and Responsibilities:** To support the operations from both direct and indirectly from the quality perspective in which the Quality Operations area, based on training assigned, the individual must: + Promote and participate safety activities at site. + Provide support and oversight to operations from product quality and compliance perspectives. + Address issues being reported during manufacturing and support investigations of the operations team. + Participate and support operations during regulatory inspections. + Conduct regular meeting with sourcing sites(Beerse) on Kaizen activities, and ensure the activities related to P2P meeting are completed on time and facilitate the P2P. + Facilitate Kaizen activity in related processes. + Support other quality functions process. + Promote quality culture at site. Quality & Compliance + Carry out the assigned work in compliance with GMP/GCTP and Compliance regulations. + Create, modify and ensure updating of procedures and work instructions necessary for carrying out work activities. + Complete the technical training assigned to the role and the related ones on time updates + Support in training and enforcing compliance (such as DI) in the production area. EHS + Carry out the assigned work in compliance with the procedures and safety regulations. + Promptly report to your supervisor all those situations that could endanger the health and safety of workers and / or the environment. + Undergo information / training sessions and health surveillance provided for their job. + See Johnson & Johnson's assets as a critical business asset which must be protected from theft, loss, destruction, vandalism, non-access authorized and malicious acts in general. Computer & Automation Systems + Correctly use the IT tools necessary to carry out the work activities. + Comply with Johnson's Worldwide Information Asset Protection Policy. Johnson & Johnson recognizes that information is a business asset crucial that they must be protected from unauthorized disclosure, theft, loss, destruction, unauthorized modification, unauthorized access and denial of the availability. **職務の要件 / Job Requirements:** 教育/経験 / Education and Experiences: + 薬学、科学または工学の学位を修了していることが望ましい Degree in Pharmacy, Science or Engineering is preferable. 知識、資格、及び技能 / Knowledge, Qualification and Skills: + 品質システムに精通している Knowledgeable of quality system. + Lean and Kaizen knowledge + Statistical skills 行動特性 / Core Competencies: + コラボレーション、チームワーク Collaboration and teamwork. + 確固たるクレドーバリュー Credo value of integrity. + 顧客重視 Customer focus. + EHS、手順に従う Comply with EHS rules and procedures at all times. \#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:** Analytical Reasoning, Business Behavior, Compliance Management, Detail-Oriented, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Assurance (QA), Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards