QC Testing Leader / 試験Gリーダー

職務内容・ミッション 試験分析機器におけるData Integrity改善活動を行う。（マネジメント兼担当者） -マイルストーン策定、進捗管理、レビュー -関係チームと協力しての問題を解決 -チーム内の取りまとめ -計測機器のCAPA立案、実行 -PJの定例会議へ参加する。 ターゲットとなる業界や企業 医薬品製造業（GMP）、分析機器メーカー 仕事のやりがい 試験分析機器のData Integrityを確保することでサイトとしてあるべき姿に近づき、高品質の医薬品を市場に提供できる体制が構築できる。 身につくスキル・経験 ・各国レギュレーションの専門知識 ・プラズマ領域の品質管理 ・クロスファンクショナルコミュニケーション能力 ・オーナーシップ 部門・部署・グループ紹介 GQ成田製薬品質部　試験グループは製品完成前までのあらゆる検査を行い、品質基準を満たしているかをチェックし、市場に製品を出す時点の品質管理に責任を持ちます。 私たちは日常業務をこなすことだけでなく、GQビジョンのもと、チームの強化や個々のスキルアップにも尽力するべく、患者さんに貢献できることを第一に考えた組織の体制を構築している道半ばです。品質に対する信頼と社会貢献を軸に、ビジネスバリューを一緒に創作できる仲間を求めています。

OBJECTIVES/PURPOSE Deputy Site Quality Head. Provide leadership of Quality Control functions. Develop and drive mid and longterm strategy and operational excellence, training/education, talent review and personnel development Accountable for and manage all aspects of Quality Control at the facility, ensuring that quality systems, laboratory compliance and related functions are in place and meet current Good Manufacturing Practices (cGMP), other regulatory quality standards and requirements. Direct and ensure that laboratory operations are effective and carried out on schedule. Direct and ensure GMP compliant laboratory operations on site. Managing application of strategic goals Achievement of defined goals and targets in order to drive the Hikari plant to reach operational and compliance excellence ACCOUNTABILITIES Support Site Quality Head as deputy. Establish strategic goals for the Quality Control organization in alignment with the global and site strategy, and drive actions as needed to ensure timely delivery of goals. Lead and manage consistency in laboratory operations and data review process among Quality Control. Drive and lead new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads 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 Control team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, 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), and SAP 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.) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, 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), and SAP 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 “Qualitiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assusrance, 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。

【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。