職種 正社員 職務明細 Forvis Mazarsについて Forvis Mazarsは世界をリードするプロフェッショナル・サービス・ネットワークです。私たちの40,000人の強力なチームは、世界中で比類のないクライアント・エクスペリエンスを提供することに全力を尽くしています。私たちは1つのチームとして活動し、協力的で統合されたアプローチをとることで、あらゆる業種や地域のあらゆる規模のクライアントに、一貫したパーソナライズされたサービスを提供しています。 1992年に設立され、日本では30年以上の経験を培ってまいりました。以来、Forvis Mazars in Japanは、日本企業、世界各国の多国籍企業、及び外国人投資家のクライアントに対して監査、税務、アウトソーシング、アドバイザリーサービスを提供する点で主要な役割を果たし、今日では、日本におけるトップのプロフェッショナルサービス・ファームとして認知されています。現在、18名のパートナーのリーダーシップのもと、約20国籍の250名以上のプロフェッショナルを擁しています。 About Forvis Mazars Forvis Mazars is a leading global professional services network. Our 40,000+ strong team is committed to delivering an unmatched client experience across
職種 正社員 職務明細 About Forvis Mazars Forvis Mazars is a leading global professional services network. Our 40,000+ strong team is committed to delivering an unmatched client experience across the globe. We operate as one team, taking
Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬(消耗品、機器含む)に係る薬事対応業務 ・製造販売業の維持・管理(更新申請手続き等、3役会議事務局運営など) ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請(承認前調査/定期調査) ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応(被監査部門への監査の実施、報告書作成保管等 1回/年) ・GVP対応(情報収集、当局報告、記録書作成保管等) ・薬事トレーニングの実施管理(年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等) ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験(1年以上) ・薬事規制(特に安全管理業務)に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力(メール対応) ・基本的なPCスキル(Word、Excel(表計算・グラフ作成)、PowerPoint) 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
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Keywords Studios is an international technical and creative services provider to the global video games industry. Established in 1998 and headquartered in Dublin, Keywords now has over 50 studios located across Europe, North America, South America
Keywords Studios is an international technical and creative services provider to the global video games industry. Established in 1998 and headquartered in Dublin, Keywords now has over 50 studios located across Europe, North America, South America
Keywords Studios is an international technical and creative services provider to the global video games industry. Established in 1998 and headquartered in Dublin, Keywords now has over 50 studios located across Europe, North America, South America
Keywords Studios is an international technical and creative services provider to the global video games industry. Established in 1998 and headquartered in Dublin, Keywords now has over 50 studios located across Europe, North America, South America
Keywords Studios is an international technical and creative services provider to the global video games industry. Established in 1998 and headquartered in Dublin, Keywords now has over 50 studios located across Europe, North America, South America
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