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Open nowPosted 118 days ago

[Japan] 滋賀品質管理チーム スペシャリスト

Santen72 open roles

Where
Hikone, Shiga, Japan
Work mode
Hybrid
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Your applicationOpen now[Japan] 滋賀品質管理チーム スペシャリストSanten · Hikone, Shiga, Japan

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Santen's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

13.4% of postings close within 7 days. Measured by our own scanner across the market. Santen postings stay open a median of 13 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.6%3 days
  3. 13.4%7 days
  4. 21.6%14 days
  5. 36.2%30 days
  6. 59.0%60 days
This job: posted 118 days ago

Santen median: 13 days open

The posting

企業概要

Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。

求人内容

<主な職務>：

・試験検査記録の判定及び承認

・標準品及び試薬の管理の確認

・規格外結果（OOS）に対する原因調査の確認・承認

・傾向異常（OOT）に対する分析及び評価の承認

・バリデーションに伴う試験検査の承認

・試験検査設備及び機器の校正及びメンテナンスの承認

・データインテグリティ要件に準拠した試験室情報管理システム（LIMS）及び関連システムの維持・管理

に関する事項の承認

・安定性モニタリングの計画・実行及び進捗管理及の承認

・参考品及び保存品の保管・管理に関する承認

・社内・社外監査への対応

・教育訓練計画の作成及び年間スケジュールに従った実行及び承認

・品質 KPIs のモニタリング及び継続的改善の推進、マネジメントへの報告

・生産部門、品質部門の戦略・目標を達成するためのプロジェクトへの参画及び貢献

＜期待される役割＞

・職務分野の専門家として高い知識・技術を有し、複雑性の高い課題に対しても、所属組織内外問わず影

響力を発揮し、課題解決に向けて自律的に業務遂行する

・職務分野のプロフェッショナルとして下位のメンバーの手本となることが期待されるとともに、チーム

マネジャーとともに組織メンバーの育成に貢献する

・生産部門及び品質部門の戦略・目標を理解するとともに、目標達成に向け、具体的な方策を自ら考案

し、状況に応じて自律的に判断をする

・利害が対立する場合においても、社内外の幅広い関係者の理解を得ながら折り合いを付け、課題解決に

向けて組織を跨いだリーダーシップを発揮する。

・所属組織内における継続的改善を推進し、継続的改善文化の醸成に貢献する

・品質管理責任者として自律して品質管理業務を遂行することができる

資格

・ 経験：医薬品業界での品質保証又は品質管理業務の経験（5 年以上が望ましい）

・ 知識：GMP、ICH ガイドライン、FDA 規則、その他関連規制に関する深い知識

・ スキル：リーダーシップスキル、コーチング及びメンタリング、コミュニケーションスキル、ネゴシエ

ーションスキル、戦略的思考、問題解決能力

・スキル：英語（中級以上）

・ その他：高い倫理観、細部への注意力、チームワークの精神

その他の情報

（業務内容の変更の範囲）当社業務全般

（就業場所の変更の範囲）本社および全国の事業所、営業所

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