募集要項
- 募集背景
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<About the position>
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 working knowledge of 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.
- 仕事内容
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The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations<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, etc.
* Function as Hinseki to support the Sanyaku organization within the Japan office
* 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
* Engaging assessment regulatory impact on product and manufacturing processes.
* Engaging site inspections, preparing audits observations response as necessary
* Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters
- 応募資格
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- 必須
- Leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance)
- 歓迎
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・Strong oral and written communication skills. Strong interpersonal and leadership skills. Established project management skills
・Pharmacist license
・Experience being in Sokatsu and Hinseki roles
・Working experience in MNC pharmaceutical/medical device/healthcare product organizations
・Experiences with CAPA systems and experiences applying regulations (GMP, Good Distribution Practices)
- フィットする人物像
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<Required Qualifications>
* B.S. Degree in bioscience, chemistry, pharmaceutical, business or technical field
* 7 years of QA experience in Pharma/Medical device or other regulated industry in total, at least 3-5 years of QA experience in a pharmaceutical and/or medical device manufacturing environment
* Proficient with MS software
* Proficient with eQMS and eDMS systems
* Ability to work independently in a fast-paced team environment with little supervision
* Ability to communicate effectively in Japanese and basic level of English
* Strong managerial, people guidance, project management and time-management skills
<Desired Characteristics>
* Strong oral and written communication skills. Strong interpersonal and leadership skills. Established project management skills
* Pharmacist license
* Experience being in Sokatsu and Hinseki roles
* Working experience in MNC pharmaceutical/medical device/healthcare product organizations
* Experiences with CAPA systems and experiences applying regulations (GMP, Good Distribution Practices)
* QC testing experience for sterile products
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY10,000,000.00 per annum + competitive
