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Open nowPosted 119 days ago

[Japan] 滋賀品質保証チーム 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] 滋賀品質保証チーム 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 119 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。

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

求人内容

【基本使命】

上位方針・戦略との整合性を担保しつつ、科学的根拠を背景にした医薬品品質システムを通じて、高品質な製品を社会に提供することを基本使命し、継続的改善を立案・実行することで「品質基本方針」及び「品質目標」を達成する。

また、担当する業務においてチームマネージャー及びチームメンバーと協働し、課題解決に向けてリーダーシップを発揮しながら自律的に業務遂行することで、チーム運営の適正化および組織目標の達成に貢献する。

＜主な職務＞

・Santen品質マニュアル、cGMP、関係する国内外の規制要件を満たす医薬品品質システムの構築及び維持管理

・製造記録書のレビュー、試験成績書（CoA）の作成、製造所からの出荷判定

・医薬品製造におけるGMPの遵守及び実践の管理・監督（現場パトロール）

・GMP文書（製品標準書、標準作業手順書（SOPs）等）及び記録のALCOA+に基づくライフサイクル管理

・データインテグリティ要件に準拠したコンピュータ化システムの維持・管理

・品質イベント（逸脱、苦情、変更、CAPA等）に対する調査、影響評価、CAPA立案の主導又はサポート

・CAPAの有効性評価

・不適合品の管理

・原材料供給業者、外部委託業者の管理

・GMP教育プログラムの構築及び改善

・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

・自己点検計画の作成及び年間スケジュールに従った実行

・社内／社外のGMP監査への対応

・製品品質照査の作成

・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

・滋賀工場全体のGMPレベル向上に向けた取り組みと実行

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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