募集要項
- 募集背景
- An international manufacturer of medical devices is hiring for a Validation Specialist. In this position, you will be responsible for executing validation procedures and producing of technical writings in addition to creating validation test designs from technical information.
- 仕事内容
-
An international manufacturer of medical devices is hiring for a Validation Specialist.Responsibilities:
* Design, author, and execute Computerized System Validation (CSV) -according to GAMP 5 guidance
* Complete technical writing of validation documents SOPs, maintenance procedures, calibration procedures, and other instrument support documents
* Translate technical information and requirements into qualification/validation test design
Requirements:
* Bachelor's Degree, preferably in a Scientific discipline
* 3+ years' experience of FDA related pharmaceutical validation
* Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
* Customer-oriented, conducting job function with a primary focus on customer satisfaction
* Competency in Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
* Experience with a multitude of laboratory equipment a plus
- 応募資格
-
- 必須
- 3+ years' experience of FDA related pharmaceutical validation
- 歓迎
- その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY5,000,000.00 - JPY10,000,000.00 per annum
