Manager or Specialist, Quality Assurance, Narita Site / 成田工場 品質保証担当（課長代理または一般社員）

【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 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。

OBJECTIVES/PURPOSE Provide leadership of the Quality Assurance functions for Active Pharmaceutical Ingredients (API) & Oral Solid Dosage (OSD) manufacturing, and Warehouse/Distribution. Develop and drive mid and long-term strategy and operational excellence, training/education, talent review and personnel development. Responsible for and manage all aspects of API/OSD/Warehouse Quality Assurance 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. Approve and manage site deviation investigations and assess product impact Drive API/OSD GMP adherence on the shopfloor in manufacturing areas Drive and manage the application of strategic goals Achievement of defined goals and targets in order for the Hikari plant to reach operational and compliance excellence Responsible for timely and effective communication and escalation processes to the Site Quality Head in order to raise quality and safety issues Responsible for the department expenses and department budget planning Ensures adherence to the EHS program ACCOUNTABILITIES Establish strategic goals for the API/OSD/Warehouse Quality Assurance organization in alignment with the global and site strategy, and drive action as needed to ensure timely delivery of those goals. Lead and ensure consistency in Deviation Investigation processes. Drive and manage Shop Floor QA activities, change control and validation execution. Manage warehouse support and pest control. Drive and lead Data, Digital, & Technology (DD&T) and AGILE programs in the Quality organization to be future ready Drive and lead new ways to improve and streamline current business and system processes. Identify, manage, and where appropriate, lead multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements. Responsible for the coaching, training, and development of the Quality Assurance team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge of the local and international regulatory regulations including GXP, International Council on Harmonization (ICH), other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products. 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 Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred. 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 Hikari 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 Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) 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 “Qualtiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

【業務体制】 　　・工程管理、リスク分析を行い最善の品質管理手順を検討するところから、依頼者への書類の移管まで、幅広く業務を行っています。 　　・標準業務手順書やマニュアルに従って業務は行われますが、これらについても常に改善することを念頭に業務を行っています。 　　・業務実施部門とチームを組んで共同作業をします。 【キャリアパス】 　　・未経験者：導入研修でGCP,SOPを学んでいただき、サポート業務からスタートします。　 　　・経験者：臨床試験の品質管理だけではなく、画像解析業務や臨床研究に関連する品質管理など、幅広くキャリアを広げることができます。 　　医療機器の申請から販売まで、書類を通じて全体像を見ることができ、品質管理の経験を活かして、ISOの内部監査や品質保証、ライティング、コンサルティング業務のスキルを身につけることができます。 【やりがい】 　　・定型業務をこなすだけではなく、意見交換しながらより業務しやすい環境を作り上げていくことができます。 　　・モニタリングQCだけでなく、画像解析や臨床研究に関連するQC、また医薬品だけでなく医療機器まで幅広い業務に関わることができます。 　　・開発業務受託機関（CRO）としての活動と、医療機器製造販売業者（医療機器メーカー）としての活動を行っており、 　　　プログラム医療機器の業界では、開発・支援の実績がNo.1です。そこにはノウハウ・暗黙知があります。 　　　それを活かして医療に貢献していくことがミッションです。