【英語を活かす】QA/RAマネージャー/ QA/RA Manager Global pharmaceutical companyの転職・求人情報 30661692

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: 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

必須: More than 5 years of experience in the QA medical industry

歓迎: 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: 完全週休2日制, 土日祝日休み, 有給休暇

会社概要

社名: Global pharmaceutical company

事業内容・会社の特長: 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

【英語を活かす】QA/RAマネージャー/ QA/RA Manager の転職・求人情報はすでに掲載終了しております。（掲載期間11月13日～11月26日）

【英語を活かす】QA/RAマネージャー/ QA/RA Manager

募集要項

会社概要

【英語を活かす】QA/RAマネージャー/ QA/RA Manager
の転職・求人情報はすでに掲載終了しております。（掲載期間11月13日～11月26日）