QA/RAマネージャー/ QA/RA Manager

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.

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

About the Company:

This company operates within the pharmaceutical industry, focusing on the development and distribution of high-quality healthcare products. As a recognised leader in its field, it is dedicated to delivering innovative solutions to improve the well-being of individuals across the globe.

Keywords:

品質保証, 医療機器, 規制, リスク管理, 規制遵守, 統計分析, 求人, 外資系

2127050/001