Tokyo Terumo Corporation/テルモ株式会社 ¥8,000,000 - ¥12,000,000
【仕事内容】

「品質保証部 QMSエキスパート(欧米・海外業務拡大)」のポジションの求人です

【背景】

テルモグループにおけるグローバル品質保証ガバナンス体制強化

【担う役割】

テルモの目指す「均質」製品品質の実現に向けて、グループ全体における

CQOの中長期成長戦略の実行と品質保証ガバナンス強化の推進。

CQO方針に基づくこれらの実行策の立案・実行・監視等。

【職務内容】

・グループ製造所の外部(各国規制当局・認証機関等)による査察、監査に対する確認および対応支援

・グループ製造所のQMS適合状況、品質保証体制確認、指導のための実地監査の実施

・国内外上市製品等の初期流動品質の確認、監査

・グループガイダンス(法的要求、ガイダンス、必須の客観的証拠、成功事例の集約)の制定と導入、浸透促進

・グループ総体のQMS適合レベル、製品品質レベルの平準化、底上げを目的とした品質改善プロジェクトの立案と推進主管

【仕事の魅力】

・規制当局(主にFDA)査察への立会い経験と製造所支援を通した規制要求知識、及び実践的な行政査察対応スキルの習得

・上記行政査察支援や、QMS監査・初期流動監査等を通した現場・現物・現実の実践

それらによる監査スキル、及び製品知識の向上

・製造所SMEとの交流によるプロジェクト対象領域の専門知識向上、及びプロジェクトの運営・推進を通したプロジェクトマネジメントスキルの向上

・欧米製造所品質リーダーや、CQOスタッフ海外メンバーなど欧米人を始めとした英語によるグローバルレベルでの業務

・業務を通した異文化への理解深耕、グローバルコミュニケーションスキル向上の機会

【求める人材】

【必須要件】

■QMS、GMPなど品質マネジメントシステムエキスパートとしての実務経験

(品質システム構築・整備、内部/外部/サプライヤ監査経験、異常品質・逸脱・苦情処理~改善活動等)

■製造所監査、内部監査経験

■品質改善業務経験(NCR・CAPA・苦情処理、など)

■英語力:ビジネスレベル

【給与】

年収 800 ~ 1200 万円

賞与:年2回(6月・12月) ※2024年度実績 5.85カ月相当

なお、経験・スキルに応じて変動の可能性があります

【勤務地】

東京都

渋谷区幡ヶ谷 2-44-1

【勤務時間】

09:00~17:45

【雇用・契約形態】

【休日・休暇】

完全週休二日(土日)土日祝日、夏季休暇、年末年始休暇、慶弔休暇、有給休暇(1年目):15日(入社日より)

休暇制度:結婚休暇、転勤休暇、忌引き休暇、障がい者特別休暇、選挙・裁判員制度参加等の公民権行使休暇、生理日休暇、出産時休暇、産前産後休暇、配偶者出産時休暇、看護介護休暇、不妊治療休暇

休業制度:介護休業、育児休業

休職制度:勤続満1年以上の方は、私傷病や、公職、MBA取得などそれぞれの事由に応じた休職期
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