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[Innovative Medicine] Complaint Quality Approver, Operational Quality Group （Fuji Plant）

年収：応相談

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部署・役職名	[Innovative Medicine] Complaint Quality Approver, Operational Quality Group （Fuji Plant）
職種	QC（品質管理） QA（品質保証）
業種	医薬品メーカー
勤務地	静岡県
仕事内容	■About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. ■Position Summary: The Complaint Handling Specialist is accountable for independent, objective review and approval of complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The Complaint Handling Specialist also supports proper complaint handling through leading investigations. The role confirms that risk is assessed, root cause and actions are adequately supported by evidence, required stakeholders are involved, and the complaint record can be closed with a clear and consistent outcome. ■Major Job Duties and Responsibilities: ・The Complaint Handling Specialist independently reviews complaint records throughout the investigation lifecycle and provides the final Quality approval before record closure. The approver confirms alignment on investigation strategy, Root Cause Analysis (RCA) is appropriate, that appropriate investigation tools are used, and that the right stakeholders are involved, including consideration of end-to-end supply chain factors as applicable. During execution, the approver supports the investigation owner by reviewing updates, requesting clarification or additional evidence, and ensuring new information and follow-up narratives are accurately integrated into the complaint (PQMS) record, including any actions required based on new information. The approver confirms risks are identified, managed and escalated, and supports actions as required. Prior to approval, the approver verifies data integrity and that conclusions (including RCA) are supported by objective evidence, confirms trending and recurrence considerations are addressed, and ensures the investigation summary and outcome are clear and aligned across sites/affiliates when applicable. Additionally, the approver will provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution. Finally, the approver verifies required actions (including NC, when applicable) are defined, owned, and appropriately tracked before approving the complaint record. ・When acting as the investigator, the Complaint Handling Specialist is responsible for conducting the investigation in accordance with the investigation requirements described above for the approver role, while closely collaborating with the market authorization holder, sourcing site, and business partners to compile the investigation report, document it in the complaint (PQMS) record, and drive the record through closure. ・The Complaint Handling Specialist is responsible for executing, managing, trending, and improving the site-based complaints process to ensure compliance with applicable requirements. ■KEY INTERFACES ・Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis. ・Complaint investigation owner(s) and cross-functional contributors (e.g., Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT). ・Other sites and affiliates (as applicable) to align investigation strategy, evidence, and outcome for site-manufactured product complaints. ・Quality leadership for escalation, risk communication, and decision alignment. ・External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results.
労働条件	■職務： Quality ■職務のサブ機能： Supplier Quality ■職務カテゴリ： Professional ■勤務地： Fuji Plant, Shizuoka
応募資格	【必須（MUST）】 ■Education and Experiences: ・Bachelor’s degree in Life Science or related discipline (or equivalent experience) is required. ・Minimum of 2-4 years of experience performing and/or reviewing quality investigations (complaints, deviations, nonconformances, or similar quality events). ・Experience working within quality systems and with applicable regulatory and compliance requirements. ・Demonstrated ability to write clear, concise documentation and provide professional, actionable feedback. ・Proven critical thinking, problem-solving, and decision-making skills. ・Strong organization, prioritization, and time management skills ■Knowledge, Qualification and Skills: ・Knowledge of complaint handling, investigations, and corrective and preventive action concepts in a regulated environment. ・Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products (as applicable to the site). ・Strong ability to review technical data and documents (e.g., batch records, test results, protocols, procedures) and identify gaps or inconsistencies. ・Ability to assess whether conclusions (including root cause) are supported by objective evidence. ・Ability to evaluate risk and ensure appropriate escalation and actions according to global and site procedures. ・Clear written communication skills to provide precise approval rationale and actionable feedback. ・Analytical skills, including ability to interpret trends and performance metrics. ・Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records. ・Business Conversation Level English/Japanese ■Core Competencies: ・Collaboration, teamwork ・Solid Credo Values ・Customer Focus ・Emphasis on EHS Rules/Procedures Compliance ・Undelayed reporting of incidents, near misses, etc. 【歓迎（WANT）】・ISO 9001 ・コンプライアンス管理・コーチング・データ編集・ベンダー選択・レポート作成・企業行動・分析的推論・制御コンプライアンス・品質システム文書, 品質標準, 品質管理 (QC) ・問題のエスカレーション・問題解決・技術に精通・持続性と粘り強さ・部門横断的なコラボレーション
リモートワーク	不可
受動喫煙対策	屋内禁煙
更新日	2026/06/26
求人番号	8830704

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