求人情報一覧

職務内容 医薬品（ワクチン）の製剤製造（包装）業務及び付帯関連業務

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.

The Opportunity As a Data Platforms Engineering leader, you'll have a business Impact and direct alignment to the Head of Data Platforms and Architecture vision. The role is a key enabler for strategy to become a Data Driven Enterprise. By connecting with Business Units and Business Functions within Global Business and with their data teams, the data platform lead will strategically architect data, processes, and technology to achieve faster time to market for life saving products. Ultimately, help to make better decisions that improve the quality and efficiency of care for patients. You will develop data driven solutions utilizing current and next generation technologies to meet evolving business needs. You will quickly identify opportunities and recommend possible technical solutions and you will develop application systems that comply with the standard system development methodology and concepts for design, programming, backup, and recovery to deliver solutions that have superior performance, reliability, and integrity. As part of our transformational journey on Data & AI in Operations, we are taking the steps to advance to Data Mesh architecture. The current Datalake exists to give all Operations units access to critical data and analytic tools at pace, accelerating their work on life saving medicines. The vision of EDS is also accelerating Operations’ data strategy of making our data Findable, Accessible, Interoperable, and re-useable. This is being achieved through the creation of a distributed data architecture, management of our data and data products which will sit as a centerpiece of this strategy and the future evolution of Data Science. Responsibilities Create best practices and thought leadership content to be used by the federated delivery teams building data solutions and data products on Enterprise Data platforms that cater to batch, streaming and real-time data. Influence stakeholders at all levels through complex engagement models with the wider cloud ecosystem not limited but inclusive of AWS foundations for Infrastructure and data technologies, Databricks, Informatica, Kafka, Managed File Transfer, and 3rd party applications, ensuring they are excited by the Enterprise Data Services vision and solution strategy. Be a 'champion’ for both customers and colleagues by operating as an expert Engineer and trusted advisor for significant data analytics architecture, design, and adoption and scaling of the Datalake platform. Provide a roadmap for modernizing legacy capabilities inherent to the current platform. Support all data platform initiatives – Data Lake Strategy, Data Engineering and Platform development, Data Governance, Security Models, and Master Data Management. Establish a collaborative engineering culture based on trust, innovation, and a mindset of continuous improvement. Utilize Industry best practices and agile methodologies to deliver solution and extract efficiency through automations in Continuous Development and Continuous Integration. Manages efforts to problem solve for engineering challenges and coordinate with project consultants and delivery/engagement managers. As a leading technical contributor who can consistently take a poorly defined business or technical problem, work it to a well-defined data problem/specification, and execute it at a high level. Have a strong focus on metrics, both for the impact of their work and for its engineering and operations. Understand the Data Platforms investments and create data tools for consumption of services and uncover opportunities for cost optimization to assist the team in building and optimizing our platforms into an innovative unit within the company. Skills and Qualifications Bachelor’s degree or higher in Computer Science/Information technology; or relevant work experience.

【Accountabilities】 ステークホルダーマネジメントとして、サービス提供のパフォーマンスを監視し、ステークホルダーに可視化し、報告すること プロジェクトメンバーに対して全体的な戦略、計画、管理指導を行うこと プログラム/プロジェクトのスコープ、スケジュール、コスト、品質を管理し、顧客/ビジネスの戦略性、要件との整合性を確保すること 顧客/ビジネス、製品/プラットフォームオーナー、テクノロジービジネスパートナーと連携し、顧客/ビジネスの戦略的ニーズを満たすテクノロジーサービスを特定すること 主要なステークホルダーとステータス、リスク、成果について積極的にコミュニケーションを図り、プロジェクトを確実に成功させること リソースの透明性を提供し、相互依存関係を管理すること。そして、積極的にエスカレーションを行い、影響を伝えること プログラム/プロジェクトのビジネス/ステークホルダーと積極的にコミュニケーションし、プロジェクト阻害要因を解決し、プロジェクトをリードすること プロジェクトの成功要因が、より広範なプログラムとどのように関連しているかを理解し、最適な結果を確実に提供すること プロジェクトが、適用されるガバナンス方針およびプロセスを理解し、遵守していることを確認すること プログラムとプロジェクト活動を常に監視し、合理化することで、最大限の価値が提供されるようにすること 標準化されたプロジェクトマネジメントのベストプラクティスとプロセスの作成、関係者へ正しく適用され、運用できる様に貢献すること

職務内容 • ワクチン商用製品、治験薬の 試験技術・マネジメント または補助業務 • 国内外関連部門、提携先からの試験法技術移転、技術的サポート • 製造部門との協働、試験サポート管理 • 国内外の試験受託機関への試験法技術移転、試験マネジメントなど

職務内容 SOPに従いGMP製造エリアでの微生物サンプリング、微粒子サンプリングを含むグレードA～Dクリーンルームの環境モニタリング業務を実行する。 水、蒸気などのクリーンユーティリティーの定常的サンプリング業務を実行する 文書改訂業務、計画書作成または修正時に支援をする。 環境モニタリング計画に従って環境モニタリングを実行する。 逸脱等に対する根本原因の調査を行い、是正・予防計画を含む調査報告書を作成する。 質問や提案を推奨する「Speak Up」を実践する。 環境モニタリング業務や製造エリアの環境に関する改善提案を行う。 コンプライアンスに関する問題を上申する。

職務内容 常に患者さんを中心に考え、その生活を豊かにするためにイノベーションを推進しています。そして、従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも組んで取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 約5万人の従業員が、約80の国や地域で働くグローバルな企業です。すべての従業員が世界中の人々の生活をより良いものにしたいという信念をもち、そしてイズム（誠実：公正・正直・不屈）を日々の業務で体現しています。私たちは、240年以上の歴史を持つ研究開発型の製薬企業としての伝統のもと団結し、優れた医薬品の創出を通じて、人々の健康と医療の未来に貢献することをミッションとして掲げています。 生物学的製剤における培養、精製工程作業およびそれに伴う以下のような周辺関連業務 製造工程や設備のバリデーション／クオリフィケーション ワクチン製造に関わるドキュメントの作成 生産トラブルの対応

仕事内容: 経営企画部門のITシステム担当者として、部門のデータ・デジタル活用を推進いただきます。そのために、ユーザエクスペリエンスの視点とＩＴ組織全体の戦略の両方の視点を持ってプロセス&システム全体を幅広く理解し最適な提案を行うとともに、責任を持ってソリューションの導入・運用を推進いただきます。 主な内容は以下の通りです。 ビジネス部門の関係者と協働してデータ・デジタル活用のニーズを収集するとともに、IT化のロードマップ・実行計画を策定する データ・デジタルの活用による、新たなビジネスプロセスの創出支援および既存のビジネスプロセスの改善をリードする IT部門が所管している、経営企画部門向けの専用アプリケーション・ソフトウェア（以下）を適切に管理し、安定稼働に必要な保守・運用、システム開発を主導する -経営会議サポートシステム（仮称：開発中） -経営理念ダッシュボード （MS Power BIベースのアプリケーション） -BSCアプリ（MS Power Platformベースのアプリケーション） 国内外のIT部門関係者と密に連携し、グローバルプラットフォームやアプリケーションの日本展開を支援する。また、関連するインフラおよびセキュリティ対応の実施を支援する ビジネス部門のゴール達成に役立つような、新たなテクノロジー関する知識を収集し応用する ビジネス部門のステークホルダーのデジタル デクステリティ向上に必要な施策を検討・実施する

職務内容 消化器及び炎症性疾患（GI and Inflammation）領域の主に日本における臨床試験に関する下記業務 開発戦略・ライフサイクルマネジメント戦略策定、開発計画立案 臨床試験計画立案と実施 臨床試験成績の医学的及び科学的評価 製造承認申請業務 治験相談に係る戦略の策定 導入案件・開発候補品目の医学的及び科学的評価 社外ステークホルダー（専門家、規制当局など）との交渉

【主な業務内容】 • 社内ソフトウェアアプリケーションのサポート • 以下の技術専門分野における小規模ソリューションプロジェクトの技術標準分析、実装、評価に参加および実行 — エンドユーザーサポート — ハードウェアのトラブルシューティングと故障対応 — オペレーティングシステム・ソフトウェアのサポート — ハードウェア・ソフトウェアツールとITILプロセスに沿った運用 【詳細な業務内容】 • 問題の調査、解決策の分析、小規模なプロジェクトの技術的な変更の実装など • 要件、整備、テスト、問題、アプリケーション統合などの分析 • ガイドラインやポリシーに沿った意思決定のサポート、またはチームメンバーに対してのサポートに関する意思決定の支援 • 技術的な分析・設計・変更・ソフトウェア設定・ハードウェアの解決支援を標準に沿って実行 • 通常業務内やプロジェクト内でのアプリケーションの開発サービスやテクニカルサポートの提供 • ビジネスソリューションの本番環境への展開サポート、エンドユーザー機器のライフサイクルプロセスとIT資産管理 • 社内ITインフラストラクチャとエンドユーザー機器の対面式サポートの実施 • 会議室や会議イベントのサポート • システム改善策の実装支援 • 品質マネジメントシステム(QMS)、ソフトウェア開発ライフサイクル(SDLC)、およびITプロジェクトライフサイクル(ITPLC)の標準、ポリシー、および手順に従ったサポートドキュメントの作成・維持 • マネージャ・リーダーからの指導と指示の下での業務遂行 • 主要なITおよびビジネスの目的/目標を理解し、自己知識を独自の作業分野で活用 【関連業務】 • 計画された取り組みに対する定期的な更新と、テクノロジー運用とプロジェクトに関するレポートの提供 • 管理業務のデータ精度を確保

職務内容 グローバル製品の中長期需要・供給・在庫バランスのモニタリングと適正化の推進 S&OP（製品軸）プロセスにおける会議のファシリテーション、及びシニアマネジメントへの報告 供給課題発生時の課題解決、及びリスクマネジメントのリード 複数生産サイトを跨ったグローバル生産体制における、ネットワークキャパシティーアロケーションの提案 SAP/IBP、SAP/ERPシステムを使ったDemand Planning/Supply Planning/S&OPプロセスの自動化及び、可視化促進 サプライチェーンの最適化に関するグローバルプロジェクトへの参画、又はリード

【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: ・Global Corporate Affairs（広報）部門のサポートを担当します。 ・GCA（特に日本）のビジネスを深く理解し、ビジネスの問題を解決するためのデータテクノロジーのソリューションを提案します。 ・DD＆T内の関係者と協力してGCAが使用するアプリケーションやソフトウェアの適切な管理とサービス提供をします。 ・As a member of Global Corporate Affairs (GCA) – Data, Digital & Technology(DD&T) in Japan, develop and maintain effective working relationships with GCA stakeholders in Japan to promote their use of data, digital and technology and support the creation of new business processes and improve existing business processes. ・ Develop a deep understanding of GCA's business in Japan and execute product delivery service within the portfolio. ・ Responsible for the day-to-day development and alignment of delivery to the strategic vision ・ Focus on delivery, release plans, and communication progress to stakeholders. ・Work with Global DD&T stakeholders to support the deployment of global platforms/applications. ACCOUNTABILITIES: GCAが主管及び利用するシステムのサポートをします。具体的には以下の業務を担当します。 1) 社内ユーザへのSharePointトレーニングの提供やサイトの設定サポート等 2) 社外Webサイトのコンテンツ作成や修正 3) 寄付管理システム、メールマガジン配信サポート、社内コミュニケーションツールのサポート 4) グローバルプロジェクトへの参加 ・Responsible for delivering operations of the products used by GCA ➢ Support internal website on the Microsoft SharePoint platform and corporate external website on CMS platform. Including (but is not limited to) maintenance, demand management, functional improvement, content editing. ➢ Provide the SharePoint training to end users and advise them how to set up collaboration site. ➢ Create/edit contents(Publish press releases and update site contents) ➢ Support donation management system, email delivery/analytics application, internal social networking service, etc. ・ Participate the global project meetings when it is required. ・ Make sure the team correctly understands the requirements. ・ Support the team in collecting ideas and setting priorities for prototyping and development. ・ Corporate with global development team and solved issues together. ・ Provide IT supports for employee events organized by GCA.

業務内容 - 医薬品（注射剤）製造業務 - 上記製造業務に付帯関連する業務（準備・片付け・清掃など） ※業務具体例 - クリーンルーム内での製造機器の操作（洗浄機、滅菌機、充填機など） - 使用する器具・部品の洗浄 - 製造環境の清掃、消毒 - 用水設備、空調設備の維持管理 - 標準作業手順書、作業記録書の制改訂などのパソコン業務 - 医薬品製造のために必要な教育の受講

OBJECTIVES/PURPOSE Regional Lead working as the Key Point of Contact / Engagement Lead for all Enterprise Data Services/solutions portfolio; including management of functional objectives/roadmaps, major projects, quarterly functional release-based activity and ongoing run activities Lead as a ‘thought leader’ and ‘domain expert’ between Business, Business IT and EDS linking technology vision and strategy with business requirements and goals (bi-directional influence) Deliver and operate within an agile methodology integrating continuous feedback and industry best practice to enhance user satisfaction and ensure a customer driven design is put first Provide leadership to regional business teams for data management solutions across all domains at senior levels of the organization and partner with leadership and external partners in building the roadmap for data enabled innovation driving business value In partnership with the EDS Transformation and Delivery Lead, architect the strategic roadmap for EDS at the functional level, ensuring that supporting teams and capabilities are on track to deliver to commitments and priorities Build and maintain positive relationships and manage dependencies/performance with key business and IT stakeholders and supporting teams aligned with overall strategy and objectives Accountable for ensuring that the solutions are built per enterprise data governance and quality standards when applicable criteria are met as per the methodology to ensure success. Track adoption and measure value continuously with a view to challenging business IT / business on prioritisation and value Drive the communication into the function/region of the EDS Services Catalog, Release Calendar / Demand Tracking and priorisation status and manage the EDS Data Services Portfolio in alignment with strategic services/solutions delivery - ensure scalable and repeatable processes are being enabled and deployed Ensure business value and data services adoption is delivered and linked to the deployment of the EDS Data Services through defined and agreed KPI’s and SLA’s Owns and communicates how the EDS Data Services portfolio is meeting business priorities, including the provision of funding to enable the regional business requirements delivery and alignment ACCOUNTABILITIES Architecting a regional/domain focused data-services strategy that connects business objectives and the EDS data-services operating model with scalable and reusable solutions leading to measurable business value Accountable as the primary interface between functional IT and business IT partners leveraging the EDS data-services catalog (bi-directional). Focus on the technology and being a technology leader between teams Directly leading the engagement for the business function stakeholders, DD&T leads and extended teams into the EDS organisation, leveraging input from the USA to ensure alignment and consistency Lead and manage alignment between EDS, business IT and IT stakeholders on a continuous basis linked to business priorities/roadmaps, data-services capabilities; people, process, technology and data Communicate and evangelise the Data & Digital imperatives as a key driver for continuous transformation linked to the vision and strategy of the DD&T/GDT/ EDS to become the most trusted, data-driven and outcomes-based pharmaceutical company Serve as the leader for data orgnaization in Japan and be responsible for setting short-term and long-term data strategy, developing the multi-domain data capability roadmap , providing guidance in day-to-day data management operations, and ensuring project milestones and department performance goals are met. Identify and collaborate effectively with EDS partners and stakeholders to align on priorities, and provide project leadership ensuring high-quality deliverables, process improvement, budgets, and timely responses to business requests and operational challenges Partner with IT and system integration vendors to lead the development of new functionalities as well as change management for enterprise data management initiatives targetted to address key business challenges. Aggregating business demand and consolidate requests as appropriate to ensure that use cases are appropriately prioritized Influence and drive domain and data management practice discussions, including the Global Data Council (GDC) and the Strategic Steering Committee. Drive and lead governance sessions to ensure the Services & Operations, Platforms Architecture and Data Services and Analytics teams are managing and coordinating services delivery in an efficient and value-driven way to support building business / business IT engagement and delivery Lead/Support domain based / cross-domain communities of practice (people / process / technology / data) with a view to increasing adoption and driving business value Mentor and lead on developing the team culture and people to ensure a highly motivated and effective team is both in place today, and developing in a sustainable way for the future DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Domain knowledge of Data, Digital and Technology organizations within pharmaceuticals or related industries Pharmaceutical data expertise a must in particular Commercial data, Health Care Provider (HCP/HCO) and their linkages/relationships Track record of managing complex supplier and/or customer relationships in matrixed organizations Hands-on functional / technical / architecture level experience linked to data-services and data-platforms within the Pharmaceutical business Expertise in the delivery of data services solutions and products linked for Pharma industry Experience / Knowledge linked to Data / AWS / API / Cloud / Analytics capabilities and functionality Experience in the Pharmaceutical business model and baseline reporting requirements and processes Leadership expertise linked to data-services (Vision, strategy and business alignment, people management, communication, influencing others, managing change) Experience leading agile teams leveraging scrum methodology Leadership Passionate leader, collaborator, team player, and individual contributor Passion to challenge the status quo and find new solutions and drive out of the box ideas Assertive, with the confidence to be voice of authority – not afraid to do what is best for Taekda/team High-energy and passionate outlook to the role and can influence those around her/him Ability to build a sense of trust and rapport that creates a comfortable and effective workplace Strong communication skills with comfort in speaking with business / business ITstakeholders Not afraid to “roll up the sleeves” and lead from the front – pushes teams to do the same Direct experience in understanding business outcomes as a key driver to ensure solutions are aligned to priorities and values Active coach and mentor whose goals are to grow and maximize the team’s potential Collaborative partner able to influence and drive accountability across organizational and domain boundaries Advocates for needed change across the organization that add to our success. Decision-making and Autonomy Extensive successful analytics operations management experience will enable a high degree of autonomy in leading decisions Demonstrative business acumen with strong cross functional communication ability Ability to build concensus on sensitive topics which require senior managers to often accept compromises based on the bigger picture view Versed in risk and comliance aspects of linked to data platforms and services, with the experience to lead discussions and engage to resolve challenging and complex topics Interaction Experience being a member of a medium-sized core team with a global mandate, which requires clear and transparent communication Experience with stakeholder management and engagement at all levels of the organisation Ability to set priorities, align stakeholders expectations and, develop and execute an associated plan of action Ability to engage effectively as a part of a team and with colleagues with different backgrounds and areas of expertise Experience in managing team members with setting and tracking performance goals and metrics Must be able to develop and maintain strong relationships globally Ability to communicate effectively at multiple levels support the Data Governance Committees and facilitates strategic and operational meetings and agendas to drive decision making. Ability to influence in a highly federated governance model as a facilitator. Ability to apply advanced principles and concepts necessary to oversee various data governance workgroups Innovation This role offers the opportunity for a high level of innovation related to Data Services enablement across technology platforms focused on Commercial, but also cross-domain and geographies Curiosity, challenge the status quo Explore, navigate the ever changing environment of data, digital and technology This role will be focused on enabling concepts linked to ‘reuse’ and ‘scalability’ across data services solutions, and engaging innovative partnerships and ideas to deliver creative solutions Complexity Must possess an understanding of how a global organization operates and comfortable influencing without authority Capable of collaborating with teams both cross-functionally and remotely, across a wide range of time zones and cultures Must have significant comfort with ambiguity

【職務内容】 医薬品（無菌注射剤）の品質保証業務 具体的には、製造部門が実施する製造作業（特に無菌室内での作業）について監視を行い、製品品質を保証するとともに、作業員への指導を行っていただきます。 その他、製造指図記録書等の記録の照査、逸脱発生時の対応も行っていただきます。