Expert for Manufacturing and Supply of Reference Standards, Quality Control / 標準品の製造と供給の担当者
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勤務地山口県
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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 |
職務内容 標準品の製造(有機合成・精製)と供給 具体的には下記の職務を担当する: 標準品候補物質を試験室内で製造(精製・有機合成)する 試験室内で製造しない品目については、社外に製造を委託する 試験室内で製造した標準品候補物質および社外で委託製造した標準品候補物質を試験依頼する 社内外の試験室・販社・規制当局からの求めに応じて、標準品を試験成績書と共に供給する その他、標準品の製造と供給に関する業務 |
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雇用形態 | 正社員 |
応募資格 |
<実務経験> 有機合成とカラム精製の実務経験(試験室スケール) HPLC, GC分析の経験 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) <学歴> 高卒以上 <スキル・資格> 有機合成に関する経験と専門性 <その他> 医薬品あるいは化学品等の製造部門・品質管理部門・技術部門での業務経験 望ましい実務経験・スキル 医薬品の製造あるいは品質管理の職務経験 医薬品に関する公定書および医薬品GMPに関する知識 英文を読み書き可能な英語力 求める人物像 仲間とのコミュニケーションを通じて、円滑に仕事を進められる方 失敗を恐れずにチャレンジできる方 仕事のやりがい 医薬品の品質管理に必要不可欠な「標準品」の製造と供給に関わる幅広い業務を経験することができます。有機合成のスキルを活かして医薬品の品質管理を学びたい方や英語力を身につけたい方に、やりがいを感じて戴ける仕事です。 本職務で身につくスキル・経験 様々な標準品を自ら合成・精製するスキル。部門会の壁を越えるコミュニケーション能力(海外の方とのコミュニケーション能力を含む)、査察監査対応、グローバルGMPの理解。 |
英語力 | 問わない |
年収 | 300万 〜 万円 |
給与詳細 |
月額(基本給):197,000円~ <昇給有無>有 <残業手当>有 <給与補足> ※給与はキャリア・能力等を考慮の上、当社規程により決定 ・昇給年1回 ・賞与年2回 |
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. 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
職務内容 このポジションの主な目的は、サイト品質システム&コンプライアンスリードと協力して、パフォーマンス能力を構築し、強化し、GMSGQ内のトレーニングに関するグローバル基準へのコンプライアンスを確保するために、サイトのGxP学習システムを開発し、維持することです。 サイトのラーニングリードは、頑健なトレーニングニーズ分析に基づいてサイトのGxP学習計画を確立し、複数の部門にわたるGXP規制対象の製造環境に関する業務上のコンピテンシー要件を提供し、サイトのニーズと事業目的に基づいてGMS学習戦略を実施する責任を負います。 GMPトレーニングの監督に責任を負う品質システムの社員と協力して、サイトのニーズを満たすために効率的、効果的、適合性のある学習システムが整備されていることを保証するために、グローバルトレーニング方針及びGOP(グローバル作業手順書)の実施を監督します。関連するアプリケーション管理と展開を含む、LMS(Learning Management System)プラットフォームの継続的な展開及び使用を管理する責任を負います。 また、任命されたグローバルラーニングチームのビジネスパートナーと協力して、頑健な学習システム要素が整っていること、及びサイトが使用するための適切な技術的学習ソリューションが提供されていることを確認します。サイトの標準構造に従い、トレーニングはサイトレベルでビジネスエクセレンスに報告し、サイトにおける品質からのトレーニング品質システム要素の監督を行っていただきます。 ACCOUNTABILITIES: The core purpose of this position is to develop and maintain the site GxP Technical Learning system to build and enhance performance capability and ensure compliance with Global standards for training within GMSGQ (Global Manufacturing & Supply and Global Quality organizations) in partnership with Site Quality Systems & Compliance Lead. The Site Learning Lead is responsible for establishing the site GxP learning plan, based on robust training needs analysis to deliver the operational competency requirements for a GXP regulated, manufacturing environment across multiple functions and for implementing the GMS learning strategy based on site needs and business objectives. They oversee the implementation of global Training policies and GOPs (Global Operating Procedures) to ensure an efficient, effective, and compliant learning system is in place to meet site needs, in partnership with Quality Systems colleague with responsibility for GMP training oversight. Responsible for managing the continued deployment and use of LMS (Learning Management System) platforms, including administration and delivery applications. The Site Learning Lead works with their assigned Global Learning Team Business Partner to ensure robust Learning system elements are in place and appropriate technical learning solutions are provided for site’s use. As per the Standard Site Structure, Training reports to Business Excellence at the site level, with oversight of the Training Quality System element from Quality at site.
- 600万〜1000万
- 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
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 Automation Standard Requirement Specification, 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