Total 2 Others level Quality Assurance / Control job vacancies in Tokyo/Osaka

SCOPE:

Based on the strategy of the U.S. headquarters, you will ensure that products manufactured and sold in Japan comply with the QMS Ordinance. Specifically, you will bear direct responsibility for maintaining the quality management system in Japan, under Sirtex Global Quality Management System and, in cooperation with overseas manufacturing sites, ensure that the quality management systems at those sites meet the requirements of the QMS Ordinance.

米国本社のストラテジーを踏まえて、日本において製造販売する製品がQMS省令に適合していることを確実にして頂きます。具体的には、グローバル品質マネジメントシステムの下で、日本における品質マネジメントシステムの維持管理に直接的な責任を持って頂くと共に、海外製造所と協力して、海外製造所における品質マネジメントシステムがQMS省令の要求事項を満たしていることを確実にして頂きます。

Candidates must reside in Japan

PRIMARY RESPONSIBILITIES:

• Establishment, Operation, and Maintenance of Quality Management Systems in Japan
  • Management Review
  • Internal Audit
  • Document and Record Control
  • Training and Education
  • Supplier Management (including management of agreements under Article 72 of the QMS Ordinance)
  • Risk Management
  • Complaint Handling
  • Nonconforming Product Control
  • CAPA
  • FCA
  • External Audit Support
  • Market Shipment Approval

• 日本における品質マネジメントシステム体制の構築・運用・維持

  • マネジメントレビュー

  • インターナルオーディット

  • 文書・記録の管理

  • 教育訓練

  • サプライヤー管理（QMS省令第72条における取り決め管理含む）

  • リスクマネジメント

  • 苦情処理

  • 不適合品管理

  • CAPA

  • FCA

  • 外部監査対応

  • 市場への出荷判定

• Ensuring Overseas Manufacturing Sites' QMS Compliance with QMS Ordinance

  • Training

  • Assessment

  • Improvement

  • Monitoring

• 海外製造所における品質マネジメントシステムのQMS省令への適合

  • トレーニング

  • アセスメント

  • 改善

  • モニタリング

• Regulatory Labeling Management

• 法定表示管理

• Regulatory Registration License Management (e.g. MAH License, Overseas Mfg. Site License, Domestic Selling License, etc)

• 業態管理（海外及び国内）

• Other Quality Assurance Activities (Including Government/Industry Relations)

• その他品質保証に関する業務（行政／業界対応含む）

SCOPE OF RESPONSIBILITIES

1. Communication

1.1. Serves as the communication point to project teams with regard to quality assurance (QA) study audits

1.2. Follows up with project teams with regard to resolution of PSI QA study audits

1.3. Liaises with PSI divisions/operational offices with regard to internal systems, process, and location audits

1.4. Liaises with vendors with regard to vendor qualification audits

1.5. Serves as the communication point for PSI Operations staff with regard to issues related to quality assurance

1.6. Serves as the communication point for PSI clients with regard to QA audits contracted to PSI

2. Planning and scheduling

2.1. Prepares, conducts, and reports QA study audits

2.2. Assembles QA study audits documentation

2.3. Takes part in the preparation, conduct, and reporting of internal systems audits

2.4. Takes part in the preparation, conduct, and reporting of internal locations audits

2.5. Takes part in the preparation, conduct, and reporting of vendor qualification audits

2.6. Takes part in the preparation, conduct, and reporting of internal process audits

3. Training

3.1. Trains PSI Operations staff in quality management topics