Quality Assurance Manager

仕事内容

Quality Assurance Manager’s position plays an important role in the GQP management performing a combination of both administrative, tactical and strategic tasks. 
The position holder ensures compliance of GQP practices with regulation and group requirements as well as supporting Tech-Ops organisation in supplying good quality product to the patients..
Job responsibilities will normally include all areas of GQP such as deviation handling, quality information management, change control, traings, document management, and audits etc.

事業内容

医療用医薬品の開発、輸入、流通、販売

必要な経験・能力

Education/Learning Experience/Work Experience
Required:
・5+ years experiences in GQP and/ GMP for medicinal products.
・Knowledge of Japanese regulation for GMP/GQP/GDP.
・Strong English communication
・Pharmacist
・Understanding of manufacturing control and quality control.
・Customer focus mind-set and provide effective solutions to others.
・Good verbal and written communication skills (both Japanese and English)
・Good business and reporting skills

Desired:
・Knowledge for basic GMP/GDP requirements of ICH/EU/US.
・ Knowledge or experience for medical device GMP management.
・ Experience with new product launches is a plus

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