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[PGS]品質オペレーションズ部 (名古屋) 品質保証課 (無菌) /Quality Operations (Nagoya) Quality Assurance (Sterile)
[PGS]品質オペレーションズ部 (名古屋) 品質保証課 (無菌) /Quality Operations (Nagoya) Quality Assurance (Sterile)-March 2024
Okazaki
Mar 17, 2025
ABOUT PFIZER
Pfizer is a pharmaceuticals and biotechnology company.
10,000+ employees
Biotechnology, Manufacturing
VIEW COMPANY PROFILE >>
About [PGS]品質オペレーションズ部 (名古屋) 品質保証課 (無菌) /Quality Operations (Nagoya) Quality Assurance (Sterile)

  Why Patients Need You

  私たちの日々の業務はすべて、製品品質と患者さんへの安全で効果的な製品の提供に対する揺るぎないコミットメントに則したものです。私たちの科学的でリスクに基づく品質文化は、柔軟性があり、革新的で、顧客志向なものです。研究開発に関わっているかに関係なく、品質文化に対するあなたの貢献が患者さんに直接影響を与えることができます。

  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

  ファイザーの献身的で効果的な品質保証チームの一員として、ファイザーから出荷する製品の評価およびレビューを実施し、製品が適切に製造され、試験されていることを確認します。あなたの有する専門知識は、製品製造における基準からの逸脱を特定するのに役立ち、品質ポリシーへの準拠を確実なものにするために、逸脱や変更管理の承認を実施します。

  あなたの持つ原則、考え、理論、問題解決スキルに関する包括的な知識を通じて、ファイザーは新しいマイルストーンを達成し、世界中の患者を支援する準備を整えることができます。

  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

  名古屋工場で製造、検査、包装、試験される製剤について品質保証業務を行う。

  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。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。製品のGMP/GQP出荷判定を行い、また出荷判定業務の効果的な管理を主導する。ワクチン製剤の国家検定業務を主導する。外部製造所で製造された製品について、品質保証を行う上で、登録事項、品質取決めでの要求事項、Pfizerの期待事項を守っていることを評価する。名古屋工場への査察に対応し、また指摘事項への対応を図る。品質保証業務に関して、継続的な査察準備活動をリードする。コンプライアンスメンバーや他のファイザーグループのコンプライアンスチームと、適切なネットワークを構築し、ベストプラクティスの共有をする。

  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:

  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 the change control as a Quality Assurance SME, including new product launch, in-sourcing, process change of existing products, etc.Driving effective management of product release and performing GMP/GQP release of product lots.Managing the national testing of vaccine products.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.

  Qualifications

  Must-Have

  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 Degree3+ years' experience in pharmaceutical manufacturing/Quality experienceCurrent 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 processesProactive approach and strong critical thinking skillsStrong collaboration, relationship management, and interpersonal skillsExcellent written and verbal communicationCommunication in English/Japanese (E-mail, Teleconference, etc.)

  Nice-to-Have

  修士号Master's degree

  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

  #LI-PFE

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