プログラム医療機器（SaMD）開発に関わる品質管理業務★東京

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】 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 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.

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.