(職務概要) 信頼性保証部顧客品質グループにおいて,法規制や社内規定(J&J Standard等)の遵守及び品質マネジメントシステムに基き,日本の市場における製品に関する不具合に関する情報(苦情)を収集し,顧客,行政に対して適切な情報提供または報告を行なう。 製造元または供給業者と連携し,適切な苦情調査を実行し,顧客への調査結果の報告を行う。 Global complaint handling groupと協同し,GlobalのSOP及びGQP•QMS省令に基づいたSOPに従った担当製品の品質等に関する情報(苦情等の情報)の報告•評価•クローズ •品質等に関する情報(苦情等の情報)の処理業務の一環によるカスタマーサービス業務として,営業担当者及び消費者とのコミュニケーション及び品質に関する情報収集 •入手した品質等に関する情報を評価し,必要に応じた製造業者(3rd Partyを含む)に対する調査依頼 •製造業者(3rd Partyを含む)から報告を受けた原因調査結果および再発防止のための是正•予防措置に対する評価結果の国内品質業務運営責任者/品質保証責任者及び品質保証•品質管理グループマネージャーに対する報告する(必須要件) 大学卒業以上またはそれと同等の資格を有する者。 •物理学,化学,生物学,工学,情報学,金属学,電気学,機械学,薬学,医学又は歯学に関する専門の課程を修了した者が望ましい。 •品質保証•品質管理または製造管理,安全管理における2年以上の経験。(医薬品または医療機器業界であれば尚可) •法令及びQMS省令の要求事項の理解と実践経験。 •ビジネス英語力(会話,読み書き) •PCに関する全般的なスキル •行政,組織及び個人間における文書及び口頭による優れたコミュニケーション能力。 •目標達成に対する強いコミットメント及び柔軟性のある実行力を有する。...
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