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 責任役員への報告
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