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[PGS]SrAssociat QualityAssurance

Okazaki, Japan

Why Patients Need You


Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve


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You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

Through your comprehensive knowledge of principles, concepts, theories of the discipline and problem-solving skills, you will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It




QA SMEとして変更管理の影響評価を行い、評価内容の効果的な管理を主導する。





Perform Quality Assurance tasks for non-sterile products manufactured, inspected, packaged and / or tested and supplied from the Pfizer Global Supply Nagoya site including but not limited to:

  • Driving effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
  • Driving effective management of product release and performing GMP/GQP release of product lots.
  • Driving effective management of the change control as a Quality Assurance SME, including new product launch, in-sourcing, process change of existing products, etc.
  • Assessing operations executed at external manufacturers for their adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations to assure product quality.
  • Participate in internal Good Manufacturing Practices {also cGMP} audits and support regulatory inspections or corporate audit activities.
  • Lead continuous inspection readiness for Quality Assurance.
  • Ensure appropriate networking and sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates.



  • 学士号
  • 3年以上の製薬業(製造部門または品質部門)での就業経験
  • 品質保証業務を行うために必要なGMPに関する知識を有すること
  • 業務に対する積極的な姿勢とクリティカルシンキングスキルを有すること
  • 組織の一員として、部門メンバーと協力して業務を行える協調性があること
  • 十分な文章力、コミュニケーション力があること
  • 日本語及び英語でのコミュニケーション(メール、テレカン等)が取れること

  • Bachelor's Degree
  • 3+ years' experience in Pharmaceutical manufacturing/Quality experience
  • Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
  • Proactive approach and strong critical thinking skills
  • Strong collaboration, relationship management, and interpersonal skills
  • Excellent written and verbal communication
  • Communication in English/Japanese (E-mail, Teleconference, etc.)


  • 修士号
  • Master's degree

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control


Client-provided location(s): Aichi, Japan
Job ID: Pfizer-4905930
Employment Type: Full Time