医薬品メーカー（先発医薬品）

職務内容 ■月次、年次決算業務 ■財務諸表作成補佐 ■会計監査、税務調査対応 ■事業計画策定、予算編成 ■予実管理 ■棚卸資産・固定資産管理 ■伝票入力、債権債務・入出金管理 将来的なライン管理職候補を求めます。

職務内容 製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う ・GMP要件に基づく試験（原材料・製品の微生物学的試験） ・査察や監査時の対応 ・試験に関する技術・技能継承 ・公定書、申請書の試験に関連する業務 ・作業改善・効率化に関する業務 ・最新技術（迅速微生物技術等）の導入に関する業務

OBJECTIVES/PURPOSE Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements Main objectives (key services) Technology selection Review Capacity Modeling developed by Engineering company Engineering and Equipment Design Safety engineering design and management Recommend strategic preparation of project for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions ACCOUNTABILITIES Acting as Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment. In detail, He/she will: Report to the engineering manager. Develop and maintain process equipment concepts and engineering scope based on approved budget and schedule. Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards and define the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment. With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment. Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Black Utilities Operations, Maintenance, Calibration, Reliability, Automation.

Job Description Please note that this job requires business level Japanese language command not only in speaking, but also in business writing and reading. Are you looking for a patient-focused, innovation-driven company that will inspire you? Be empowered to take charge of your career and future. Join us as a Title in our Location office. global, R&D-driven biopharmaceutical company. We have an unwavering dedication to put people first and we live our values of ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Futurefor people worldwide through leading innovation in medicine. Here, you will be a vital contributor to our inspiring, bold mission: The Power Platform Engineer combines Microsoft Power Apps and Power Automate technical skills with business process knowledge to craft low code solutions used to enable digital transformation . The Engineer consults with business teams to recommend process solutions based on business requirements, working closely with both end users and the larger Digital Workplace team. Key Responsibilities Platform Engineering A detailed professional skilled in PowerApps and Power Automate solution design and development in order to support client business needs. Use a strong sense of logical process to translate business requirements into technical steps, as well as make recommendations for process improvement. Act as the liaison between clients, colleagues, and business partners in delivering solutions. Able to recommend the right combination of Power Platform tools for each scenario, understanding when it is beneficial to use Dataverse, SharePoint, or other sources as part of a solution. Work in an agile environment and be responsive to changes in platform features. Willing and able to work as part of a global team.