エージェント取り扱い求人

Vaccine Environmental Monitoring Staff/ワクチン環境モニタリング担当者(正社員/契約社員)

募集中
  • 勤務地
    山口県
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 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。
雇用形態 契約社員/正社員
応募資格 <実務経験> 
医薬品の製造あるいは品質管理業務に関する職務経験
医療機器の製造・品質管理業務(微生物試験あるいは環境モニタリング)に関する職務経験
シフト勤務に対応できる(生産需要が高い時期は2交代制のシフト勤務になる場合があります。)
<学歴>
高卒以上
<スキル・資格> 
正確にデータ入力や資料作成を行う能力(Word/Excel等のPCスキル)。
個人およびチーム環境でも業務を遂行できる能力。
マスクを含む無菌衣を着用し、業務を遂行できる。
<語学力>
英語力:読み書き可能なレベル
望ましい実務経験・スキル
無菌的環境での環境モニタリング業務経験
微生物学的試験
環境モニタリング業務
逸脱調査と報告書作成
トレンド解析
求める人物像 
協調性がある。
人を思いやることができる。
責任感がある。
論理的思考ができる。
批判的ではない。
適切なコミュニケーションができる。
偏った見方をしない。
仕事のやりがい
自分たちの業務を通して、大切な患者様の健康のために確かな品質の医薬品を届けることができる。
高品質な医薬品を安定的に供給することによる社会への貢献ができる。
高い効能を持った高品質の医薬品を安定して供給するために努力する会社の一員として仕事ができること。
世界水準での業務を行うことができる。
本職務で身につくスキル・経験
世界標準の医薬品GMP要求事項の理解と実践
汚染防止の概念
グローバルサイトの専門家との交流
英語力 読み書きレベル
年収 300万 〜 万円
給与詳細 300万円-
勤務地 山口県
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

関連する求人

エージェント取り扱い求人
Head of EHS, Osaka Plant

esponsible for the following matters in Osaka Plant In collaboration with the plant management, lead the development and implementation of management systems and site procedures concerning environmental, health, safety using the ISO14001(Environment) and ISO45001(OHS) Lead EHS related compliance including waste water management Strive for sustainable global envirionment with zero-emission and carbon neutral Lead projects of Safe Initiative program, BCP, and security to formulate annual plan by closely monitoring the transition Ensure the requirements of corporate EHS and other related departments are in place Supervise / host EHS-related committees or meetings Lead EHS programs in association with Osaka plant restructuring with duties of government and neighboring affairs Elevate the capabilities of Osaka Plant organization for now and the future through the cross-functional collaboration Evaluate change proposals from the EHS aspects (for example, Safety, legal response and so on) on the change management process, as a EHS SME Ensure ethics and compliance DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise: Have theory-based systematic and practical knowledge on Environment Occupational Health and Safety for fulfillment of duties Comprehensive understanding of regionally emerging EHS legislation and experience of proactively responding to legislation changes Proven experience in auditing against EHS management systems Capability to train people in EHS&S methodologies Strong analytical skills and ability to convert informational data into action plans Strong customer service and responsiveness to others Sense of urgency and ability to achieve results Leadership: Make quick and practical decisions in case of emergency Provide leadership and direction to achieve the safety workplace vision through management commitment and employee ownership Take initiatives in EHS-related projects in Osaka Strong results orientation, leadership capabilities and overall structured way of working Decision-making and Autonomy: Set goals and processes in line with corporate EHS starategies and policies Facilitate senior level decision making in relation to people management practices Interaction: Create, develop and maintain relationships within GMSGQ Japan and with other divisions, affiliated companies, external experts and government office for prompt execution of EHS measures at Osaka Plant Strong interpersonal skills to get along with all levels of the organization Lead improvement of local, regional, and national EHS issues around the site Innovation: Develop and implement solutions by observing and referring to similar EHS issues within and outside the company Lead and engage team members for the AGILE program to drive continuous improvements and innovation Complexity: Ability to translate complex information into simple actions Extensive and pragmatic view beyond the site Coordinate EHS strategic matters with each department and affiliated companies in Osaka Plant

  • 1300万〜1700万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Coordinator, Spare Parts, Engineering, Hikari Plant/ 光工場 エンジニアリング スペアパーツ コーディネーター(契約社員)

募集部門の紹介 光工場(山口県)エンジニアリング部は、医薬品製造工場の設備(建築、機器、空調、配管、電気、計装)に関するオーナーズ・エンジニアリング業務(自社の立場に立ったエンジニアリング業務)を実施している部門です。 職務内容 予備部品管理者/管理者の指示の下、予備部品及び保全資材の受領、保管、移動を含む、効率的かつ効果的な日常の物品管理活動 予備品倉庫/保管室の物理的セキュリティの日常的なモニタリング及びすべてのセキュリティ関連の問題の管理者への報告 Efficient and effective daily warehouse activities, including the receipt, storage, staging and movement of spare parts and maintenance materials under direction of Spare Parts Supervisor / Manager Day-to-day monitoring of physical security in the spare parts warehouse/storeroom and the reporting of all security-related issues to management

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Automation Engineer, Japan New Plasma Facility Project

As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities* in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems** meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Ensure compliance with Takeda Automation Standard Requirement Specification, Takeda Automation Engineering Guideline, compliance, and cybersecurity in the project. 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 automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. * Automation Security & Integrity Engineering Automation Solutions & System Engineering Automation Data Engineering Automation Data Governance Engineering **

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

募集中

エージェント取り扱い求人
Platform Operations Manager

ACCOUNTABILITIES Serve as the Platform Operations Manager. Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers. Influence the existing complex landscape and solutions by innovating, redefining and simplifying process and technology designs, propose and execute solutions to identified highly complex IT pr Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers.oblems or process driven agile approaches. Drive the Platform Operations by creating, monitoring and adapting the processes and metrics for the products and platform. Owns the processes around Platform support, including monitoring and alerting, as well as escalation and post-mortem processes. Owns the 24x7 platform operations management and relationship with ICC/ICS and operations outsourced provider. Support the platform team to Introduce new capabilities, delivering business outcomes, in terms of speed to value and mean time to repair as well as client satisfaction. Ensure advanced capabilities are in steady operation, using scripted infrastructure and automation techniques. This will require collaborate with existing teams who currently manage our deployments to maintain a proper production system. Work independently on tough problems with other team members and independently solve, with some guidance, very difficult technology problems. Demonstrates advanced tooling and techniques to other technical organizations throughout the company. CORE ELEMENTS RELATED TO THIS ROLE Provision, manage and maintain the infrastructure that supports plaform and the customers. Identify and execute improvement actions for platform operations, including championing exploration and incubation of advanced technologies. Track, manage, and communicate platform operations performance. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Work independently on highly complex problems with other team members and independently solving, with some guidance, very difficult technology problems. Demonstrates advanced infrastructure tooling and techniques to others across the rest of IT. Demonstrated in depth knowledge of key patterns and industry awareness of trends in the bio/pharma industry with a specific focus on Patform operations. Leadership Ability to manage direct reports and influence ICC/ICS and 3rd party providers to deliver at appropriate levels of quality, response times, stability and agility. Ability to manage and influence the general platform community across Takeda to a modern ecosystem. Align and Drive agile and platform driven operations groups to a better end-state. Decision-making and Autonomy Ability to drive our third-party support teams to maintain a stable analytics ecosystem. It will require the need to make tactical decision when needed to our operational environments. Ability to work through/complex and propose proper technology choices. Independently manage day to day operational issues while knowing when to escalate more critical problems or decisions in the environment. Interaction Interact with and influence cross functional team members, including Platform teams, Functional Leads, Business Partners, Product Owners and others. Coordinate and oversee plafform architecture, engineering and delivery teams at a technical level and coordinate different technical aspects across the ecosystem. Align with Enterprise Architecture, Platform Team and Quality Teams to make sure services co-exist with other best practices and deployments. Complexity Ability to distill complex operational feedback into actionable strategies, implementations and stable deployments. Ability to have an agile time-based delivery team operate within a traditional project and waterfall-based funding and approval cycles. Drive complex deployments to implementation and deployment. Many of these solutions are difficult to make stable at scale.

  • 900万〜1300万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中