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エージェント取り扱い求人
Technology Support Engineer, Osaka / 技術サポートエンジニア 大阪_ID:751

【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武田薬品の標準に沿って実行 • 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 • 武田薬品の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

  • 500万〜800万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Associate Director, Global Master Planner, Supply Chain Management / サプライチェーンマネジメント部 グローバルマスタープランナー

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

  • 500万〜800万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
コミッショニング&クオリフィケーション担当 シニアバリデーションエンジニア、光工場エンジニアリング部課長代理

【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。

  • 500万〜1300万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
GCA Japan Digital Communication IT Product Owner (Manager or Staff)- ID: 550

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 Takeda 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(Takeda.com)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 Takeda end users and advise them how to set up collaboration site. ➢ Create/edit Takeda.com 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.

  • 500万〜1300万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Operator, Sterile Manufacturing, Hikari Site/ 光工場 注射剤製造担当者(契約社員)

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

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
EDS Data Management Lead

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 Takeda 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 Takeda 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 Takeda 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

  • 500万〜800万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Manager or Specialist, Quality Assurance, Osaka Site/ 大阪 製品保証担当者(課長代理または一般社員)

【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。

  • 500万〜1300万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Operator, Plasma Manufacturing, Narita Site / 成田工場 血漿分画製剤 製造担当者(契約社員)

【職務内容】 - 医薬品(注射剤)の製造作業(分画、精製、製剤、検査包装の4グループで構成されています) - 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(配属グループ及び経験スキルに応じます。) - クリーンルーム内外での製造機器の操作 - 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 - 製品検査・包装 - 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

  • 300万〜万
  • 千葉県
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Operator, Plasma Manufacturing, Narita Site / 成田工場 血漿分画製剤 製造担当者

【職務内容】 血漿分画製剤(無菌注射剤)の製造作業ならびに製造設備の管理を担当いただきます。 ・原料の出納作業および保管管理 ・調製・充填・乾燥・巻締等の製造作業 ・注射用水の製造作業 ・注射剤の検査・包装作業 ・製造各工程の改善活動、教育活動

  • 300万〜万
  • 千葉県
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Chapter Engineer (or Manager) Operation Technology (OT) Shopfloor Endpoint & Cyber Security

OBJECTIVES/PURPOSE The Critical Infrastructure Management – OT Shopfloor Endpoint & Cyber Security Chapter Engineer (or manager) offers specialized expertise and carries out site-specific activities and services to present manufacturing applications to shopfloor users. The job holder provides feedback to the Service Management of the Chapter and serves as a local partner for operations and project deliveries. This role is responsible for planning, implementing and coordinating global cyber security controls and standard operating procedures (SOP) to prevent or minimize cyber security risks at manufacturing sites in Japan and globally by collaborating with stakeholders Provide comprehensive and independent oversight and governance to ensure manufacturing, quality and supply chain systems comply with the required SOPs and cyber security risks strategy and plans Implement standard solutions that align with the global security strategy in order to assure business continuity and mitigate security risks at the manufacturing sites as well as accelerating the business strategy Act as site contact to comprehensively cover the cyber security field in manufacturing sites (including Industrial Control System (ICS)) by collaborating with stakeholders (e.g. Engineering, business in plants, global data & technology, etc.) ACCOUNTABILITIES For Critical Infrastructure Management Chapter OT Shopfloor Endpoint & Cyber Security Services: Operates CIM OT Shopfloor Endpoint Services needed to publish shopfloor applications on Global Manufacturing and Supply & Global Quality (GMSGQ) sites, following global CIM standards and procedures. Represents the CIM OT Shopfloor Endpoint & Cyber Security team at site and/or region, collaborating with local and global teams. Partners within Data, Digital & Technology (DD&T) and CIM chapters to support defining/evolving standards and site level deliveries. Holds interfacing service providers accountable withing the service operations processes. Runs continuous monitoring and improvement. Builds & upgrades OT Shopfloor Endpoint & Cyber Security environments. Acts as Point of Contact for site-level security requirements, approvals, and maintenance, including site-level incident response activities. Acts as Point of Contact for global-level security requirements to align with the global security related programs / projects. Builds and conducts communication plans for cyber security matters with relevant departments at manufacturing sites in Japan (e.g. Engineering, business in plants, global data & technology, etc.) Builds and conducts communication with global functions (e.g., global security team, network team, IT infrastructure / architecture teams, etc.) for cyber security matters. Reports cyber security activity objectives, progress, issues, etc. to senior leadership directly or in meeting bodies. Manages operations of cyber security related activities with stakeholders based on plans as well as aligning with global cyber security strategies. Develops plan of security awareness campaigns, organization, and education for manufacturing sites in Japan. Oversees periodic security assessments and initiates change based on results. Monitor. site-level adherence to global and site-specific security procedures Manage continuous monitoring and improving of the cyber security environment. Plans, manages, and facilitates security scanning and testing in manufacturing sites in Japan ADDITIONAL INFORMATION Travel Requirements – Ability to travel up to 60-70% to the factories (Osaka, Narita and Yamaguchi prefecture) if the candidate is hired at Tokyo.

  • 500万〜1300万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

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エージェント取り扱い求人
Staff, Vaccine QA Quality Operations / ワクチン 品質保証(クオリティ・オペレーションズ)担当者 (契約社員)

職務内容 ・製造および試験設備の導入に関連する文書レビュー ・技術移管関連の文書レビュー ・バリデーション関連の文書レビュー(バリデーションマスタープラン、プロセスバリデーションなど) ・GMP製造のための文書レビュー(マスターバッチレコード、試験法など) ・製造時の品質保証業務(現場監視、実施済のバッチレコードレビューなど) ・ワクチンの出荷に関連する業務 当局査察の対応 ※ご経験やキャリア志向を勘案して、上記の中から担当業務を幾つか選択させていただきます。

  • 500万〜800万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

NEW
エージェント取り扱い求人
Technology Support Engineer, Hikari Plant / 技術サポートエンジニア 光工場

【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武田薬品の標準に沿って実行 • 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 • 武田薬品の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

  • 500万〜800万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

NEW
エージェント取り扱い求人
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】 光工場における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 チームリード: 生産計画と出荷計画に基づいて試験計画を作成・実行 無菌試験 エンドトキシン試験 微生物限度試験 マイコプラズマ否定試験 培地充填試験 微生物同定試験 環境調査、工程使用水の微生物学的試験 試験業務に関連する専門知識を共有してチームメンバーの能力向上を推進

  • 500万〜1300万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

NEW
エージェント取り扱い求人
Specialist, Vaccine Drug Substance Manufacturing/ ワクチン原薬製造担当者

職務内容 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 当局の査察の対応 生産トラブルの対応

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

NEW
エージェント取り扱い求人
Commissioning & Qualification Lead, Japan New Plasma Facility Project

ACCOUNTABILITIES Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team. Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate. Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills. Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards. Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. Ability to present a course of action to management and project team using both written and verbal communication tools. Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections. Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report commissioning and qualification costs including capital and cross-functional expenses. Perform other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures. Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team management. Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

NEW
エージェント取り扱い求人
Commissioning & Qualification (CQ) Engineer, Japan New Plasma Facility Project

OBJECTIVES/PURPOSE This position will provide support to the execution of commissioning and qualification of a new Plasma manufacturing facility. This position is responsible to assess and qualify equipment, critical systems (utilities), facilities, computer systems, cleaning processes, manufacturing processes, as applicable. Primary tasks include development of protocols, coordination of commissioning and qualification activities, qualification execution, preparing final reports and assembly of final commissioning and qualification packages, and generation of project plans. Responsibilities will consist of both initial commissioning and qualification efforts as well as re-commissioning and re-qualification. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and will be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis. ACCOUNTABILITIES Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculums, routine project procedures, project management, and other training as appropriate. Performs a variety of projects/studies in several areas at the same time to support project timelines and budgets while maintaining quality and compliance. Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills. Handles routine tasks with attention to detail, timely and accurately. Participates and interfaces with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification elements, as applicable, to determine commissioning and qualification strategy based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and qualification. Emphasis is on ensuring accuracy and integrity on commissioning and qualification documentation that meets regulatory guidelines and industry standards. Writes protocols and reports, executes, interprets, and evaluates commissioning and qualification documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.). Utilizes Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identifies gaps related to commissioning and qualification requirements and global procedures. May assist in closing compliance gaps as they are identified. Performs updates to element commissioning and qualification assessments and commissioning and qualification plans, as required. Participates, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions. Supports internal or external assessments or audits, as required. Supports process with timely closure of observations/audit items. Uses commissioning and qualification test equipment in support of commissioning and qualification activities. Performs other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have basic experience in pharmaceutical/biotech commissioning and qualification elements, as applicable, including the writing and executing of protocols and standard operating procedures. Must have basic knowledge of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, a successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中