[PGS]品質オペレーションズ部 サイトコンプライアンス課 一般社員/Staff, Site Compliance, Nagoya QO

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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
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
  • 国内外ならびにファイザーのガイドラインに沿った製造活動を管理・支援する。
  • 国内外の行政ならびにファイザー社内の査察の準備ならびに対応を主導する。
  • GMP文書、教育ならびにData Integrity強化活動を推進およびサポートを行う。
  • 行政登録に必要な薬事対応や輸出関連の書類作成を行う。
  • 品質問題、CAPA、ロット処置の決定に対して効果的な管理を主導する。品質、技術面で複雑な案件を含む。
  • その他、工場内のGMP活動(逸脱処置、変更管理、業者管理、バリデーション)全般のサポート
Perform Quality Assurance tasks for drug products manufactured, inspected, packaged and / or tested and supplied from the Pfizer Global Supply Nagoya site including but not limited to:
  • Managing and supporting manufacturing activities in line with domestic and international and Pfizer guidelines.
  • Leading preparation and taking actions for domestic and international government and Pfizer internal inspections.
  • Promoting and supporting GMP Documentation Control, Training, Change Management and Data Integrity enhancement activities.
  • Creating pharmaceutical regulatory affair documents necessary for administrative registration to domestic and exported countries.
  • Driving effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
  • Support for all other GMP activities (Deviation Management, Change Control, Vendor Management, Validation).
  • 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: On Premise
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

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Japan

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 13, 2024
Company Overview

Current Openings: 0

Breakthroughs That Change Patients' Lives: Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.To learn more, visit www.pfizer.com. For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines Beware of scams from individuals, organizations and Internet sites claiming to represent Pfizer in recruitment activities. A formal Pfizer recruitment process is required for all authorized positions posted by Pfizer prior to issuing an offer of employment. This Pfizer process includes an interview and never requires payment or fees from job applicants. If you receive a suspicious email message or phone call about recruiting on behalf of Pfizer, do not provide any personal information or pay any fees. Interested candidates should apply to current openings through this Pfizer website. Pfizer accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
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