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      Urgent! Sr. QA Auditor Position in Tokyo - IQVIA
 
                        
                         **【ポジション名】**
  
  
**Sr.QA Auditor (監査対応)**
  
  
**【会社紹介・ビジョン】**
  
  
**私たち**  **IQVIA**  **は、ヒューマンデータサイエンスの先駆的な企業として、医療・ヘルスケアの前進に取り組む皆様を**  **IQVIA**  **ならではの革新的なソリューションによってご支援することで、「誰もが、より健康に自分らしく生きられる社会」の実現を目指しています。世界最大規模を誇る医療・ヘルスケア関連データを基盤に、人・データ・サイエンスを融合させた見地から、未だ満たされない治療ニーズに応える、新たな医薬品や医療機器の開発と市販化、厳格化する規制やコンプライアンスへの対応、持続可能な医療システム推進の支援など、患者さんをはじめとするすべての人々のために、より良い未来へと医療・ヘルスケアを前進させていく力となることが、私たちの使命です。**
  
  
**世界**  **100**  **以上の国と地域で約**  **9**  **万人が活動する**  **IQVIA**  **の日本法人として、**  **IQVIA**  **ジャパンでは約**  **6,000**  **人が一丸となり、この使命に向かって日々、力を尽くしています。**
  
  
**【**  **主な業務内容**  **】**
  
  
外勤、出張あり
  
  
**・臨床試験実施に係る監査業務(GCP/臨床研究等の監査業務)全般**
  
**-監査計画の立案と作成、監査報告書に従った監査の実施、監査報告書作成、CAPAレビューとフォローアップ**
  
**・その他社内QA業務(コンサル、適合性調査、顧客監査対応等)**
  
  
**【**  **求める人物像**  **】**
  
  
**■必須**
  
**臨床試験に関する監査業務経験**
  
**・医薬品/医療機器開発業界、GCP業務経験5年以上**
  
  
**(うちGCP監査経験3年以上あれば尚可)**
  
**・GCP関連の国内外法規制の理解**
  
  
**・英語:読み書き、SOPが理解できる**
  
**・複数のプロジェクトを同時に管理する能力**
  
**・同僚、マネージャー、クライアントとの良好な関係を構築・維持する能力。**
  
  
**【歓迎(WANT)】**
  
  
**・医療機器、再生医療、医師主導治験、臨床研究等の専門知識**
  
**・システム監査等の経験**
  
**・ビジネスレベルの英語力**
  
  
**【このポジションの魅力**   **】**
  
  
**1.
グローバルな監査経験を積める環境**
  
**• グローバル試験等に関わる監査を担当し、国際的な規制(ICH-GCP、FDA、EMA等)にも対応する実務経験を積むことができます。**
  
**• 多国籍チームとの連携を通じて、グローバルな視点と英語力を活かせる・伸ばせるポジションです。**
  
**2.
品質保証のプロフェッショナルとしての成長機会**
  
**• eQMSを活用した監査ライフサイクル管理、CAPAレビュー、教育・トレーニングなど、QAの中核業務を幅広く経験できます。**
  
**• SOP改善やプロセス最適化など、組織全体の品質向上に貢献する提案・実行の機会も豊富です。**
  
**3.
多様な試験形態に対応する専門性**
  
**   • 企業治験だけでなく、医師主導治験や特定臨床研究など多様な臨床研究の監査経験を積むことができ、キャリアの幅が広がります。**
  
**4.
柔軟な働き方と働きやすい環境**
  
**• ハイブリット勤務及びフレックスタイム制度を導入しており、ワークライフバランスを重視した働き方が可能です。**
  
**• 経験豊富なチームとの協働により、相互に学び合える環境が整っています。**
  
**5.
キャリアアップを支援する制度**
  
** QAリーダーやマネジメントへのキャリアパスも視野に入れた成長支援体制があります。(希望すれば社内異動も可能)**
  
  
**【勤務地】**
  
  
**東京 大阪**
  
  
**【雇用形態・**  **勤務時間・**  **福利厚生・**  **休日休暇**  **】**
  
  
**雇用形態:正社員**
  
  
**勤務時間:**  **9:00-17:30**
  
  
**フレックス勤務:**  **あり**   **(フルフレックス)**
  
  
**在宅勤務制度:あり**
  
  
**福利厚生:**  **法定内**  **(社会保険制度)**  **・法定外**  **(**  **IQVIA**  **独自制度)**  **の両面から充実した福利厚生制度**  **あり**
  
  
**受動喫煙対策:あり**
  
  
**休日休暇:**  **年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇·**  **など**
  
  
**試用期間:あり(通常6か月)**
  
  
**【**  **給与・待遇**  **】**
  
  
**給与:**  **当社規定により優遇します**
  
  
**昇給:**  **あり**
  
  
**賞与**  **:**  **あり**
  
  
**時間外手当:**  **あり**
  
  
**【**  **選考プロセス**  **】**
  
  
**書類選考→人事面談→部門面接→対面面接**
  
  
**【応募方法】**
  
  
**日本語の履歴書及び職務経歴書をご準備ください。**
  
  
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at  https://jobs.iqvia.com
  
  
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create connections that accelerate the development and commercialization of innovative medical treatments.
Everything we do is part of a journey to improve patient outcomes and population health worldwide.
  
  
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.
No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.
Thank you for your interest in growing your career with us.
  
  
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Unlock Your Sr QA Potential: Insight & Career Growth Guide
Real-time Sr QA Jobs Trends in Tokyo, Japan (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Sr QA in Tokyo, Japan using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 782 jobs in Japan and 222 jobs in Tokyo. This comprehensive analysis highlights market share and opportunities for professionals in Sr QA roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! IQVIA is currently hiring and seeking a Sr. QA Auditor to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Sr. QA Auditor Jobs Tokyo.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at IQVIA adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Sr. QA Auditor Jobs Japan varies, but the pay scale is rated "Standard" in Tokyo. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Sr. QA Auditor typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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            Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Sr. QA Auditor interview at IQVIA, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the IQVIA's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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