外資系大手化粧品会社／Quality Technical Manager
2025/04/11- メーカー : 化粧品
700～900万円
- 化粧品->品質管理
- 千葉県
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Position Summary The Quality Control and Testing Manager ensures the safety, efficacy, and quality of quasi-drugs and cosmetics while focusing on physicochemical testing and product quality management. Based in Yachiyo, Chiba, with a hybrid work model and flexible hours, this role reports to the Quality and EHS Director. Key responsibilities include overseeing physicochemical testing at domestic manufacturing facilities, such as appearance testing, pH measurement, and impurity analysis, managing product quality testing processes, and ensuring compliance with specifications. The manager also standardizes testing procedures, investigates anomalies, and manages testing equipment calibration and maintenance. While maintaining compliance with Japanese regulations, including the Pharmaceuticals and Medical Devices Act, this role emphasizes hands-on quality control and testing activities over administrative GQP-related tasks. This position requires at least 5 years of experience in quality assurance or quality control for quasi-drugs, cosmetics, or other medical products, with expertise in physicochemical testing methods. Strong communication and problem-solving skills and the ability to work effectively in Japanese (business level) and English (TOEIC 600+ or equivalent) are essential to ensure regulatory compliance and continuous improvement. ポジション概要 クオリティ・テクニカルマネージャーは、医薬部外品および化粧品の製造業（包装・表示・保管）の責任技術者として製品の安全性及び品質を確保するため、理化学試験と製品品質管理に重点を置いた業務を担当します。このポジションは千葉県八千代市を拠点とし、ハイブリッド勤務と柔軟な勤務時間が可能です。 主な業務内容は、国内製造施設での理化学試験（外観検査、pH測定、成分分析など）の監督、試験手順の標準化、異常値の調査、試験機器の校正・保守管理です。また、日本の規制（医薬品医療機器等法など）を遵守しながら、製品品質試験検査プロセス全体を管理します。 応募資格として、医薬部外品や化粧品、その他医療製品の品質保証または品質管理で5年以上の経験、理化学試験の専門知識が求められます。日本語（ビジネスレベル）と英語（TOEIC 600以上）のコミュニケーション能力も必要です。 1. Basic Information Job Title: Quality Technical Manager (Product Quality Management) Department: Quality Assurance Department Position: Junior Manager Job Purpose: To ensure the safety, efficacy, and quality of quasi-drugs and cosmetics through rigorous physicochemical testing and product quality management while maintaining compliance with relevant regulations and upholding the company’s credibility. Reporting to: Quality & EHS Director Location: Yachiyo, Chiba (Hybrid work model with flexible hours available) Communication: Japanese (native or business level) and English (TOEIC 600+ or equivalent, with the ability to communicate effectively in a professional setting) 2. Required Qualifications and Experience At least 5 years of experience in quality control or assurance related to quasi-drugs, cosmetics, or other medical products. Expertise in physicochemical testing methods (e.g., UP/HPLC, pH Measurement, Sensory Tests, UV-Vis spectrophotometry, Hair Dye-Specific Tests etc…). Basic understanding of the Pharmaceuticals and Medical Devices Act (Japanese regulatory framework). Strong communication and problem-solving skills. 3. Key Responsibilities 3.1 Development and Maintenance of Quality Standards and Procedures Develop, revise, and maintain standard operating procedures (SOPs) and Product/Quality Master File for product quality management. Ensure clarity and documentation of testing standards and methods. 3.2 Oversight of Physicochemical Testing Oversee physicochemical testing of quasi-drugs conducted at in-house domestic manufacturing facilities. Specific Physicochemical Testing Activities: ・Appearance Testing: Inspect foreign matter's color, shape, and presence. ・pH Measurement: Measure acidity or alkalinity to confirm compliance with specifications. ・Content Testing: Quantitatively analyze active ingredients and additives (e.g., using HPLC or UV-Vis spectrophotometry). ・Impurity Testing: Detect and quantify impurities or residual solvents to ensure compliance with specifications (e.g., using HPLC). Viscosity Measurement: Assess the viscosity of liquid or semi-solid products. And other necessary tests. 3.3 Product Quality Testing and Results Management Ensure that product quality testing is conducted appropriately and complies with specifications. Review test results to guarantee the integrity and reliability of the testing process. Investigate anomalies in test results and implement corrective actions as needed. Judgement of release products to a Japanese market on behalf of the MAH and report to the GQP Manager periodically. 3.4 Equipment Management Manage testing equipment, including calibration, maintenance, and validation. Ensure that all equipment meets regulatory and operational standards. 3.5 Handling Complaints and Market Recalls Record customer complaints accurately, investigate their causes, and implement appropriate responses. Manage market recalls as needed and report to relevant regulatory authorities. 3.6 Training and Education Develop and implement training programs related to physicochemical testing and product quality management to enhance employees’ knowledge and skills. 3.7 Document and Record Management Manage quality-related documents and records appropriately, adhering to retention periods and ensuring accuracy and completeness. 3.8 Regulatory Correspondence and Inspection Preparedness Respond to inquiries from regulatory authorities and provide necessary information. Prepare for inspections to ensure compliance with Japanese regulatory standards. 3.9 Risk Management Assess risks throughout the product lifecycle and implement appropriate risk mitigation measures. |