プログラム医療機器（SaMD）開発に関わる品質管理業務★東京

OBJECTIVES/PURPOSE Provide leadership of Quality Systems & Compliance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel development Managing aspects of Quality Systems & Compliance of drug substances and drug products at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), other regulatory quality standards and requirements. ACCOUNTABILITIES Manages the Quality Systems & Compliance organization making sure the site goals are cascaded into the department. Ensure that quality related computerized systems including TrackWise and DMS/LMS are effectively implemented across the site. Ensure that change control process is in place and all changes are appropriately assessed, necessary actions are taken and the changes are implemented. Maintain validation programs and review and approve validation documents. Manage and host overseas/domestic regulatory inspections or audits. Create documents associated with manufacturing license and communicate with regulatory authorities. Generate APQR associated with products in Narita and approve them. Organize Quality Management Review and monitor and control Quality KPI/Metrics. Investigate cause of customer complaints and create investigation reports. Maintain supplier management programs and qualify suppliers/service providers. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines. Knowledge in Plasma Derived Therapeutic processes including sterile operations and packaging operations. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in both Japanese and English. Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Change Control/Complaint/Inspection and SAP systems. Leadership Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the leadership behaviors throughout the GQ organization and Narita Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Interaction Interacts with the Site Head and all site functions (Business Excellence, EHS, HR, Finance, IT, Manufacturing, Engineering and Supply Chain) Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators. Interacts frequently with subordinates, functional peers, and the Senior Leadership Team. Innovation Strong knowledge of Quality Risk Management principles. Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products. Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business. Lead and engage employees by initiatives of “Quality Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assurance, Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

職務内容 SOPに従いGMP製造エリアでの生菌サンプリング、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 SOP改訂業務、プロトコル作成または修正時に支援をする 査察や監査の際にSMEとして環境モニタリング業務の内容を説明する 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 環境モニタリングトレンド解析をおこない、 逸脱等に対する根本原因の調査を行い、CAPA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 環境モニタリングに関するProjectへ参画する。 コンプライアンス違反を報告する。

募集部門の紹介 国内最大工場で、医薬品原薬・医薬品を製造しています。その品質管理を行う部門で原料の受け入れから出荷まで一貫した試験を行っています。今回、応募している部門は、試験部門で試験を実施するのみでなく、チームリーダーを担うことができる方を求めています。将来的には一つのグループのマネージャーにチャレンジしてみたいという方に是非応募していただきたいポジションです。工場はグローバル化が進んでおり、グローバル基準のGMPを経験したい、海外の方と業務をしてみたいという方にも是非。 工場の所在地は山口県光市です。自然豊かで、気候の穏やかな地域で、工場は瀬戸内海の海岸沿いに立地しています。山にも近く、自然を愛する方、自然の中でゆっくり過ごしたい方には絶好の場所です。 職務内容 品質試験の実施、および品質試験のチームを率いる小グループのリーダー若しくはリーダー候補。

【職務内容】 下記の主な業務を担当していただきます。 ・現場作業の監視・監督 ・逸脱調査 ・製造記録や試験記録などの照査 ・バリデーション ・変更管理 ・査察準備及び対応業務