Quality Specialist 免疫診断事業部品質管理担当者

Thermo Fisher Scientific Tokyo, Tokyo

About the Job

【管理薬剤師業務 石岡勤務】

・製造所における製造管理者業務:手順書改定、監査補助、製造所の管理
・向精神薬輸入業:業務の維持・管理
・卸売販売業の管理薬剤師:手順書改定、業務の維持・管理
・海外製造所への連絡:メールでのコミュニケーション、不具合品の発送等


Job Title: Quality Assurance Specialist

Division Summary:

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.

The mission of Immunodiagnostics Division (IDD) is to dramatically improve the management of allergy, asthma, and autoimmune diseases by providing healthcare professionals with advanced diagnostic technologies and clinical expertise, and the mission of Clinical Diagnostics Division (CDD) is to be the leading provider of high value, innovative diagnostic solutions to select IVD market segments and a partner of choice or major OEM customers.

Job Responsibilities: Quality assurance specialist at warehouse

  • Regular control of product’s delivery into domestic market
  • Lead change control of designated products at warehouse
  • Creating and maintaining QMS documents and records in accordance with QMS Ordinance
  • Collaboration with internal and external contributors including overseas counterpart
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments when applicable
  • General regulatory and maintenance tasks

Minimum Qualifications:

  • Pharmacist
  • Understanding PMD Act, QMS ordinance and regulatory guidelines/regulations to implement QARA jobs
  • Experience of working in In-Vitro Diagnostics, medical device or pharmaceutical industry for over 3 years in quality department
  • Business level written and oral skill

Preferred Qualifications:

  • English reading & writing skills