Head of Non-Sterile Quality Assurance (Director)

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。

【職務内容】 医薬品（無菌注射剤）の品質保証業務 具体的には、製造部門が実施する製造作業（特に無菌室内での作業）について監視を行い、製品品質を保証するとともに、作業員への指導を行っていただきます。 その他、製造指図記録書等の記録の照査、逸脱発生時の対応も行っていただきます。

【職務内容】 光工場において、医薬品の品質管理及び品質保証業務における以下業務を担うリードもしくは担当者です。 ・ショップフロアQA（現場作業を直接監視・監督） ・バッチレコードを含む書類の照査 ・逸脱調査 ・出荷判定　 ・バリデーション ・変更管理 ・試験記録のレビュー など 業務範囲は、光工場の生産部門及び試験部門であり、対象製品は原薬／固形製剤、麻薬製剤などがありますので、適性と経験を考慮します。 【キャリアの展望】 この業務を経験されると、国内外の医薬品に関する品質保証業務全般の知識スキルを習得する事が出来ます。また、光製薬品質保証室には、原薬、固形製剤、無菌製剤、ワクチンを担当するグループもあり、品質保証室内のローテーションにより幅広い剤型に対する品質保証エキスパートになれる機会が得られます。

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.