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Quality Management

Tokyo 23 Wards
Permanent
¥5,000,000 - ¥10,000,000
  • Apply
  • Email Job
  • Save Job

Bullet points

  • GCP監査責任者、SOP管理事務局Chair、信頼性保証機能の責任者を目指せる

  • 世界が注目する創薬技術を有する将来有望な製薬企業

About Our Client

企業名非公開 *秘密保持契約のため

面談時に詳細な情報を共有させていただけますと幸いです

Job Description

■臨床試験における品質マネジメント担当者として、イシューマネジメント(CAPAマメジメントを含む)を関係部署とともに実行する。
■当局査察対応業務(査察準備、ファシリテーション、トレーニング等)
■臨床試験等(Clinical, MA領域)のプロセス改善へのアドバイス

The Successful Applicant

【必須要件】 下記全てに該当される方
■製薬企業又はCROで品質マネジメント/品質管理業務あるいは臨床試験関連業務に5年以上従事し、臨床試験

におけるイシューマネジメント(CAPAマネジメント*を含む)知識および実務経験をお持ちの方
*イシューの原因分析、CAPAプラン実行の推進、CAPA対応のクローズを管理
**臨床試験のリスクマネジメントプロセス推進役として治験の開始から終了までのリスク管理
■GCPの知識(ICH-GCPや国内外規制)を有し、臨床試験のプロセスに精通している方
■品質マネジメント(ISO9000シリーズ等)の基礎的な知識をお持ちの方
■英語でのコミュニケーション能力(電話会議、メール、資料作成が可能、目安としてTOEIC700点以上)

【求める人物像】

■柔軟な思考とチームで協業可能なコミュニケーション力と調整力

■クロスファンクショナルな活動場面で課題解決をリード、またはファシリテート可能なスキル

What's on Offer

500万円〜1000万円 ※経験スキルなどを考慮し、上下する可能性がございます。

■昇給:年1回 ■賞与:年2回

<標準的な労働時間>8:45〜17:30 (所定労働時間:7時間45分)

休憩時間:60分 時間外労働有無:有

<フレックスタイム制> コアタイム:なし

その他福利厚生については、面談時に共有させていただきたく存じます

Contact:
Ken Odagiri
Quote job ref: 19801
+813 6832 8906
Save Job
Apply
Quality Management

Job summary

Function:Life Sciences
Specialisation:Pharmaceutical
Industry:Healthcare / Pharmaceutical
Location:Tokyo 23 Wards
Contract Type:Permanent
Salary:¥5,000,000 - ¥10,000,000
Company Type:Japanese Corporate
Consultant name:Ken Odagiri
Consultant phone:+813 6832 8906
Job Reference:19801

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