CAPEX Project Director, Japan New Plasma Facility Project
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勤務地大阪府
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職種その他製剤化/製造・生産関連職
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業種医薬品メーカー(先発医薬品)
募集要項
業務内容 |
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. |
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雇用形態 | 正社員 |
応募資格 |
EDUCATION and BEHAVIOURAL SKILLS: Bachelor’s degree in engineering, science or other technical field (engineering degree preferred). Minimum 10 years experience in running/managing projects/programs with total costs over 20 Oku Yen. Project Manager certification by IPMA or PMI is a plus. Project controlling and scheduling High strategic thinking. Quality and EHS awareness. Awareness of project risks and effective mitigation planning. COMPETENCIES AND SKILLS: Leadership and problem solving skills. Influencing and collaboration skills. Facilitation and presentation skills. Effective communicator of project technical information to senior management. Applies effective scheduling and cost estimation/controlling strategies and tools. Strong financial and business acumen. Ability to assess and manage stakeholder expectations. |
英語力 | 問わない |
年収 | 1300万 〜 1700万円 |
給与詳細 |
月額(基本給):310,000円~ <昇給有無>有 <残業手当>有 <給与補足> ※年収は前職の経験を考慮の上、規定により決定します。 ■昇給:原則年1回 ■賞与:年2回 |
勤務地 | 大阪府 |
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. global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. 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
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
職務範囲 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 将来においては、弊社他事業場、並びに当社の海外医薬品製造関連会社への異動の可能性もあります。
- 900万〜1300万
- 千葉県
- 医薬品メーカー(先発医薬品)
募集中
職務内容 成田工場における新規設備大型更新、および新製品導入・既存製品増産に伴う設備導入・新棟建設等のプロジェクトの実行メンバーとなり、成田工場の未来を作り、ビジネスの堅強な成長を直接支える業務です。 医薬品製造設備の各導入プロジェクトの担当者として以下の業務に従事いただきます。 - 設備仕様の検討 - 予算策定、管理、購入検討 - 工事設置、生産立ち上げ - 機器や製造プロセスに関するレビューや技術的サポート - スケジュール管理・リスク管理 - 社内外の関係者との調整・交渉 - FDA等の規制監査対応 ※新規設備のFeasibility調査からクオリフィケーションまで、また既存設備の向上等多岐に渡ります。
- 500万〜800万
- 千葉県
- 医薬品メーカー(先発医薬品)
募集中
職務内容 主力生産工場にて、低分子医薬品、高活性医薬品の製造に関する下記業務を担当いただき、早期上市、安定供給および生産性向上に貢献いただきます。 ・新製品の工業化に向けた化学合成プロセス検討 ・国内外の製造委託先への技術移管及び技術指導 ・工場における原薬製造のプロセス改良およびトラブル解決 ・国内外での薬事申請・照会対応、ならびに当局・販社の査察対応 ・原薬製造プロセスへの新規技術の適用
- 900万〜1300万
- 山口県
- 医薬品メーカー(先発医薬品)
募集中