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東京都の品質管理の求人203件応募資格・募集要項・仕事内容を見る
品質保証責任者 QA Leader & Hinseki PDx Japan
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
社内外の要求事項を満たすシステム・ルール・プロセスの構築および維持を行い、プロジェクトや製品が規定された品質基準を満たす状態を確保します。日本における品質保証機能を牽引し、GQP省令およびPDxのGDP/GMP QA規制への準拠を推進するポジションです。製品リリース、苦情対応、CAPA、倉庫運営などのQAプロセスを担い、品質管理レビューや規制リスク管理、監査対応などを行います。
この求人に応募
応募資格
必須
- B.S. Degree in bioscience, chemistry, pharmaceutical, or technical field
- At least 7 years of experience in pharmaceutical and/or healthcare products industry or other regulated industry
- At least 3-5 years of QA experience in a pharmaceutical and/or healthcare products manufacturing environment and/or country office affiliate operations environment (at least 3 years in a supervisory or managerial role)
- Proficient with MS Office word processing, spreadsheet, presentation, and database applications
- Proficient with eQMS and eDMS systems, for example TrackWise and Veeva Vault respectively
- Proficient with ERP/WMS systems such as SAP
- Proficient with teleconferencing software platforms (MS Teams)
- Ability to identify root cause of problem and creatively problem solve to gain resolution.
- Ability to work independently in fast-paced environment with little supervision.
- Ability to adapt to constant change and influence positive change effectively. - - Team-oriented, with experience in work with cross-functional teams across local and global scope and responsive to customer needs
- Quality-focused, attentive to detail and results-oriented
- Ability to communicate effectively in Japanese and intermediate level of English.
- Strong managerial, people guidance, project management and time-management skills
- Strong analytical, logical and critical thinking skills and abilities
歓迎
- Pharmacist (preferred but not mandatory for Hinseki track, mandatory for Sokatsu track)
- Experience being in Hinseki and/or Sokatsu roles
- People leading/managing experience
- Working experience in MNC pharmaceutical/healthcare product organizations
- Experiences with CA/PA systems (GEHC electronic QA system)
- Experiences applying regulations (GMP, GDP, GQP)
- QC testing experience for sterile products
- Technical transfer experience for QC test or manufacturing process for sterile products
募集要項最終確認 11/5
- 職種
- 品質管理
- 雇用形態
- 記載なし
- 役職
- Quality Assurance Leaderleading the Quality Assurance function in JapanFunction as Hinseki to support the Sanyaku organization within the Japan office, with eventual progression to Sokatsu
- 給与
- 記載なし
- 勤務地
- Minato, Tokyo, Japan, 108-0074
- 働き方
- 記載なし
- 経験年数
- 3年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/13 06:28（23日前）
- 最終確認
- 2026/11/05 01:18（今日）
仕事内容
Job Description Summary
- 本ポジションでは、社内外の要求事項を確実に満たすためのシステム・ルール・プロセスの構築および維持に携わっていただきます。また、プロジェクトや製品が適切に機能し、規定された品質基準を満たす状態を予防的な観点から確保することが求められます。
- 業務にあたっては、ベストプラクティスを踏まえながら、ご担当領域が他部門とどのように連携するのかを理解し、組織全体を見据えた推進力を発揮していただきます。さらに、市場における競合状況や自社の差別化要因にも目を向け、ビジネス視点を持って取り組んでいただきます。
- 日本における品質保証リーダーとして、品質保証機能全体を統括し、担当領域および専門分野において現行規制（GQP省令）の遵守をリードしていただく重要な役割です。これらを通じて、継続的な事業成長および組織強化に貢献いただきます。
役割概要 / 目的
- 品質保証リーダー（品責）として、日本における品質保証機能を牽引していただきます。担当領域および専門分野において、現行規制（GQP省令）に加え、PDxにおけるGDP/GMP QA規制への準拠を確実に推進し、事業および組織の持続的な成長を支えていただくポジションです。
- Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
- The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance) with regards to the area of responsibility and specialization in support of continuous business and organizational growth.
Role Summary/Purpose
- The Quality Assurance Leader (Hinseki) is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance) and PDx GDP/GMP QA regulations with regards to the area of responsibility and specialization in support of continuous business and organizational growth.,
Essential Responsibilities
- Own the QA process under, e.g., Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, SOP and documentation management, etc.
- Function as Hinseki to support the Sanyaku organization within the Japan office, with eventual progression to Sokatsu
- Lead the preparation and execution of Quality Management Reviews for the region
- Manage quality evaluation of warehouse operations, manufacturing sites, and external laboratories
- Provide support to routine activities, projects, development and training relevant to area of expertise where required
- Support continuous improvement activities regarding areas of responsibility
- Support local business growth in line with global quality practices and local commercial priorities
- Engaging assessment regulatory impact on product and manufacturing processes.
- Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met. Includes liaison with other GEHC functions, industry bodies or regulators as required
- Identify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisions
- Engaging site inspections, preparing audits observations response as necessary
- Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters
- Support Global supplier quality audit activities
- Working with local CMOs and global manufacturing to maintain continuous product quality excellence
- Key quality support for regulatory product-specific inspections
- Correspondence with PMDA and Tokyo Metropolitan Office Health Authority
Quality Specific Goals
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals , and applicable laws and regulations (GQP ministry ordinance) as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Ensure on-time reporting of the metrics for quality management reviews.
この求人は、GEヘルスケア・ジャパン株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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