Compliance Engineer or Manager / エンジニアリングサービスグループ、コンプライアンス担当/課長代理

職務内容 医療用医薬品やワクチン等の製造設備について以下の業務に従事いただきます。 工場全体の設備・機器・計装の校正の実施 設備・機器・計装の校正の実施に責任を持ち、規格通りに製品が製造されることを保証する メンテナンス部門、製造部門等と協同し、最適な校正の実施 校正記録のシステム管理(CMMS: Computerized Maintenance Management Systems) 校正業務の継続的な見直し

【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、コンピュータ化システムバリデーション業務を担当します。 担当工事のコンピュータ化システムバリデーション責任者として、コンピュータ化システムを検査し、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 ・バリデーション作業の調整 ・バリデーションの実施 ・バリデ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/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.

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