募集要項
- 募集背景
- A renowned pharmaceutical company is seeking a QA/RA Manager. The selected candidate will be responsible for implementing QA strategies, ensuring regulatory compliance, and overseeing quality systems.
- 仕事内容
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A renowned pharmaceutical company is seeking a QA/RA Manager.Responsibilities:
* Oversee the generation and review of documents related to good manufacturing practices and audits of production and quality control areas
* Provide expertise in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance and effectiveness
* Manage document control and quality systems, including training and electronic quality systems
* Handle non-conformance, corrective actions, preventive actions, and deviations
* Collaborate in the development of overall direction, processes, and systems for the Quality organisation
* Support regulatory submissions and ongoing compliance for the product development process
* Review device labelling and advertising materials for global regulatory compliance
* Review and sign off on product and manufacturing changes for regulatory compliance
* Approve submissions, including design and manufacturing changes, and test protocols
* Oversee Risk Management and provide input on design verification, validation, and shelf-life studies
* Provide technical guidance and mentorship to QA staff and cross-functional teams
* Develop and implement departmental policies and procedures
Requirements:
* Bachelor's degree or above in a technical field
* More than 5 years of experience in the QA medical industry
* Proven experience in Quality Management and Risk Management
* Proficient in PMDA and international regulations (e.g., FDA)
* Strong technical knowledge of medical devices
* Proficient in MS Office Suite and Adobe Acrobat
* Business level English and Japanese
- 応募資格
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- 必須
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More than 5 years of experience in the QA medical industry
- 歓迎
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Proven experience in Quality Management and Risk Management
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY9,000,000.00 - JPY14,000,000.00 per annum
- 休日休暇
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完全週休2日制, 土日祝日休み, 有給休暇
