. ポジション概要: GQP/GMP省令に基づいて制定される品質システムの各手順書（SOPs）及び品質標準書、品質システムで作成される様式等、その文書管理業務全般の運営・維持管理を担当いただきます。規制当局の査察に対応できる強固な文書管理システムの策定及び運用を通じて、製品品質、コンプライアンスの遵守に努めます。 また、GQPの出荷判定業務において、出荷判定関連文書の一次レビューを担当いただきます。 職務内容: GQP省令、ICHQ10に基づくGQP手順書（SOPs）、品質標準書の改訂。 Global SOPとLocal SOPのギャップ分析及び国内規制要件に基づく適切な改訂。WEB文書管理システムへのSOPsの登録。 Data Integrityに基づく文書・紙媒体での保管管理、電子媒体でのバックアップ管理。それら文書の適切な廃棄。 GQP品質保証業務における年次照査報告書の作成。 GQPの出荷判定業務における一次レビュー、並びに出荷判定関連書類の作成。 その他のGQP・CMC関連業務。 職務経験: 製薬企業でGQP/GMP分野での文書管理の実務経験（3年以上） 薬機法、GQP/GMP省令に基づくData Integrityに関する基本的な知識 Word, Excel, PDF編集ソフト等を活用した文書作成・データ管理 GMP/GQPでの出荷判定関連業務の経験を有する方（GQPでの経験を歓迎） 製造販売業の品質保証部門での業務経験（3年以上を歓迎） 必要とする能力・スキル: 細部まで注意を払い、正確かつ着実に業務を遂行できる方 関係部署（薬事部、サプライ＆ディストリビューション、製造所等）とスムーズに意思疎通が図れるコミュニケーション能力 規制動向や社内プロセスの変化に対し、柔軟かつ主体的に対応できる方 英語：ビジネスレベル 資格／免許: 特になし Whatever your area of expertise, your
Job Description: Department Overview The System Division is an organization where you can engage in all tasks related to all system, such as planning, development, operation and maintenance, etc., ranging from developing core business systems to
Valeo is a tech global company, designing breakthrough solutions to reinvent the mobility. We are an automotive supplier partner to automakers and new mobility actors worldwide. Our vision? Invent a greener and more secured mobility, thanks
Job Title:Senior Engineer, Materials Quality Engineering Job Description: The Role: We are seeking a dynamic Senior Engineer in our Materials Quality Engineering team (Supplier Quality) for our regional Japan supplier base and Japan manufacturing operations. In this role, the
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Job Title:Manager, Materials Quality Engineering Job Description: Manager, Materials Quality Engineering We are seeking an experienced and forward-thinking Manager of Materials Quality Engineering (MQE) based in the Tokyo office to lead a regional team supporting critical raw materials and
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職種 正社員 職務明細 国内外大手2社の合弁会社で､高い安定性を実現！ ビルメンテナンスの国内パイオニアであるグローブシップ㈱と、世界の総合施設管理大手の仏ソデクソ (Sodexo S.A.) との合弁会社が、｢グローブシップ･ソデクソ･コーポレートサービス株式会社｣です｡ 両社のノウハウやネットワークを生かして､国内の工場や事業所向けに設備管理や清掃、警備､備品調達など､ 総合施設管理（IFM: Integrated Facility Management ）事業を展開｡ これにより､今まで以上のサービス展開､質の向上､安定した取引を実現させています｡ 当ポジションの方には、埼玉県熊谷市に位置する、当社の取引先である外資系製薬会社の妻沼工場に当社メンバーと共に常駐していただき、当社が取引先に提供している施設管理業務サービスによって発生する品質管理業務をご担当いただきたいと考えております。 詳細は下記の業務内容をご確認ください。 スキル・資格 【必要スキル】 - 生産設備における品質管理の実務経験 - 日本語での文章作成能力、校正力 - 顧客やチーム内での円滑なやりとりのための日本語コミュニケーション力・折衝力 - 品質問題を調査・解決するための分析能力・提案能力 - 英語力（読み書き） 【歓迎スキル】 - 施設管理および工場生産分野での実務経験 - 医薬品製造要求事項および規格の知識 - ビジネス英会話
As a leading game localization company, we offer integrated text, audio localization and localization QA for all regions, languages and platforms, ensuring a fully authentic offering for players worldwide. Our global footprint across Asia, Oceania, Europe,
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J.P. Morgan Asset Management is a global leader in investment management, committed to providing exceptional service and innovative solutions to our clients and business partners. This is a newly created growth position within J.P. Morgan Asset
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