Microbiology Lead or Analyst / 微生物試験チームリード(課長代理) または 担当者

【職務内容】 医療用医薬品やワクチン等の製造設備について以下の業務に従事いただきます。 ・作業指導書に則った製造設備の予防保全 ・保全受託業者への指示、管理・監督業務 ・報告書および記録書の照査 ・保全・修理作業の際に十分な安全対策を実施していることを保証する ・設備のトラブル時の修繕

OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting.

【職務内容】 医薬品製造設備や工場建屋の新設工事ならびに改良工事における、クオリフィケーション業務を担当します。 担当工事のクオリフィケーション責任者として、医薬品製造設備、重要なシステム(ユーティリティ)や施設を検査し、適切な仕様を満たしているかを評価します。 ・以下の主な業務に従事いただきます。 プロトコール作成 クオリフィケーション作業の調整 クオリフィケーションの実施 クオリフィケーション報告書の作成 上記業務を実行するにあたり、製造部門、エンジニアリング部門、品質管理部門が日々連携して業務を行います。

OBJECTIVES/PURPOSE Deliver optimal designs, operating procedures and maintenance programs for GMP and non-GMP Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Maintain accurate, consice, effective, up to date operating procedures and maintenance plans for Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Drive continuous improvements through defect elimination in System Design, Operations and Maintenance program and processes Support Sustainability initiatives related to Plant Utilities Systems (e.g. energy, water, waste reduction) ACCOUNTABILITIES Acting as a Plant Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for utilities (black and clean) and sustainability related activities. In detail, He/she will: Report to the Engineering Manager. Develop and maintain utility concepts and engineering scope based on the approved budget and schedule. Ensure that all utility systems meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with the external design company on the procurement strategy and procurement packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Manage the resolution of technical issues.