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Job Function
Quality
Job Sub Function
Customer/Commercial Quality
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description
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、苦情処理プロセスの効率化、正確化、迅速化を目指し、社内関連部門、グローバル苦情調査部門、並びに製造元と連携して品質情報処理プロセスを適切に実行することへの責任を担う。また、QMSに基づき、顧客から受領した品質情報に対しリスクをもとに適正な評価を行うことで、市場での品質に影響がある事象を的確に検知し、国内品質業務運営責任者/品質保証責任者、並びに安全管理責任者へ迅速に情報提供する責任を担う。 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と共に、顧客要求事項を踏まえた製品品質改善、価値提供に向けた取り組みを支援する。 社内関連部門、ステークホルダーとの関係構築を図り、良好なコミュニケーションを維持し、部門目標達成に向けての業務遂行、関連プロジェクトへの参画、メンバーへの育成支援、製品苦情に対する顧客対応等の業務を円滑に行う責任を担う。
Duties & Responsibilities
・営業部門等(Technical Service部門を含む)より収集した品質等に関する情報(苦情等の情報)に対し、社内規定(国内規定、J&J Standard等)、並びに関連規制(GVP、QMS、GQP等)に則った情報の評価を行い、製造元及び供給業者における関連部門と協働し、原因調査、報告を行う。
・営業部門(Technical Service部門を含む)と連携し、苦情に対する調査結果を顧客に報告する。
・顧客より収集した苦情の中で、メディカル苦情(健康被害案件)について、安全管理部門と連携し、迅速かつ適切な情報収集を行う。
・国内における苦情の傾向を監視し、特異な傾向が見られた際には、製造元及び国内品質業務運営責任者/品質保証責任者に共有し、原因調査及び改善の活動に参画する。
・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を国内品質業務運営責任者/品質保証責任者に報告し、国内における必要な措置をサポートする。
・内部・外部監査では関連エリアのSMEを務め、指摘事項に対して改善計画を立案・実行に責任を負う。
・回収/改修作業において、信頼性保証部の一員として迅速かつ円滑な作業をサポートする。
・定められた品質目標(QRC部門目標)を達成すべく、チームメンバー育成のためのサポート、円滑な業務遂行及び目標達成を支援する。
Experience & Education
・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
Required Knowledge, Skills, Abilities, Certifications/Licenses And Affiliations
・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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