Manager or Staff, Japan CMC & Devices Regulatory Affairs, Development Center Japan

職務内容 標準品の製造（有機合成・精製）と供給 具体的には下記の職務を担当する： 標準品候補物質を試験室内で製造（精製・有機合成）する 試験室内で製造しない品目については、社外に製造を委託する 試験室内で製造した標準品候補物質および社外で委託製造した標準品候補物質を試験依頼する 社内外の試験室・販社・規制当局からの求めに応じて、標準品を試験成績書と共に供給する その他、標準品の製造と供給に関する業務

OVERVIEW Project Controls Engineer Are you ready to take on complex challenges while building your career? Are you interested in helping ensure that projects operate at the highest quality, within a Site Engineering team that manufactures life-saving treatments for patients? Join us as a Project Controls Engineer in Osaka Plant. Every day, Engineers at changing lives, impacting millions, and shaping the future of healthcare. On our Site Engineering team, you will be empowered to implement comprehensive project cost and schedule planning, control processes, and manage risk in support of successful project delivery. You will have the authority to make choices that contribute to our greater purpose of improving people's lives while protecting our planet. Supported by talented and respectful colleagues, you will be offered stimulating experiences that enhance ongoing career opportunities. ENGINEER YOUR FUTURE ● Develop and manage comprehensive Basis of Schedule and Cost Estimate and integrate construction planning efforts. ● Develop manageable cost and schedule packages for use by the project team. ● Ensure schedule has complete scope coverage, procurement milestones are considered, critical path defined, and potential scope growth identified. Utilize industry and internal benchmarks to validate the quality of the overall schedule. ● Analyze cost performance, maintain the monthly cash flow forecast, and ensure control of budget and spend using an approved project change request process, including allowances and contingency. ● Monitor resource plan and periodically perform Earned Value Analysis where applicable. ● Work with key stakeholders to identify cost and schedule risks and apply quantitative risk analysis methods (e.g., Monte Carlo Simulation) where applicable. ● Develop and deploy appropriate project change management processes and risk mitigation procedures. ● Develop and prepare monthly cost and schedule reports based on project definition and execution phase. ● Lead subcontractors invoice management. Track the budget, expenditures, and Estimate At Completion. ● Assist procurement during the bidding process and tendering period by assessing proposed cost against budget. ● Ensure purchase requests are based on initial budgeted scope (or approved scope changes), place and approve Purchase Requests in Ariba, and monitor the purchase process. ● Liaise with site finance departments to ensure accruals and further reconciliations are updated.

職務内容 医薬品（注射剤）包装業務 - 上記製造業務に付帯関連する業務（日々の業務報告・トラブル対応・準備・片付け・清掃・改善活動など） ※業務具体例※ 包装機器の操作およびマニュアルでの包装作業 包装機器及び包装室の5S（整理/整頓/清掃/清潔/躾)活動 製造にかかわるドキュメントの制改訂などのパソコン業務

職務内容 製造設備の導入、建設プロジェクトにおけるプロセス（生産・製造）機械の設計業務（詳細設計・予算算出・実行管理・試運転・引き渡し) 生産、研究、管理設備に関するユーザー部門への技術的サポート（導入、更新、改善） GMPに関する技術情報管理、新技術評価