職務概要 DESCRIPTION : l このポジションの第一の役割は,製造管理者として当該製造所の製造管理,品質管理及び品質保証部門の活動を監督するとともに,海外製造所における問題解決や戦略策定,業の管理,コンプライアンスの推進,当局•製造販売業者との円滑なコミュニケーションを行うことなどである。 l 本ポジションは高度な GMP に関わる知識経験が求められる。 l チームのサポートとして他の GMP 業務や規制薬物管理業務を担当する。 l また,新規モダリティ関連製品の導入に際し,有益な知見•洞察を行うことも求められる。 法規制の順守に関する責任 /REGULATORY COMPLIANCE RESPONSIBILITIES: 当該製造所が以下に示す規制要件に遵守していることが求められる。 l GMP /GCTP l 薬局等構造設備規則 l 日本薬局方等の公定書 l 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律 l 毒物及び劇物取締法等の安全に係る法律 l 麻薬及び向精神薬取締法 職務の詳細 ESSENTIAL DUTIES: 重大な逸脱•変更,承認書整合性確認,製品品質照査,マネジメントレビューなどに対する品質•薬事判断
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Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
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【勤 務 地】 東京 【部 門】 ストラテジックエンタープライズ事業本部 インシュアテック本部 【ポジション】 Account Executive（保険領域） ■ SASとは？ 企業の経営課題解決を支援するアナリティクス・ソフトウェアとサービスのリーディングカンパニーです。アメリカで1976 年に創業して以来、40 年以上連続した成長を続けており、全世界で約83,000 サイトで SAS が採用されています。1985 年のオフィス設立以来、国内において 1500社以上の実績を誇り、幅広い顧客にアナリティクス・ソフトウェアとサービスをご活用いただいております。SASでは、アメリカ本社を始め数多く国で、毎年GPTW（働きがいのある会社）のサーベイで上位にランキングされています。 ■ アワード 2024年 Chartis RiskTech100の総合ランキングで第2位 2023年 Asia Risk AwardsにおいてIFRS 17 solution of the yearを受賞 2023年
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iCapital is powering the world’s alternative investment marketplace. Our financial technology platform has transformed how advisors, wealth management firms, asset managers, and banks evaluate and recommend bespoke public and private market strategies for their high-net-worth clients.
