BRSコンサルタント
Martin Tsvetkov
Pharma
求人番号:Job-00203538
掲載日:2024-03-03
QA Manager
QA Manager
1000 - 1200 万円
東京
製薬
品質保証 / 品質管理
募集要項
- 会社概要
- 同社は医薬品、医療機器の開発を行っています。
- 業務内容
-
- Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
- When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
- Ensure full compliance with applicable regulations in Japan.
- Oversee all activities or responsibilities that are delegated to external parties.
- 応募条件
-
- 5+ years Knowledge of relevant in Quality Assurance in healthcare industry.
- Experience of complaint handling
- Experience in both clinical and post-marketing environment.
- Understanding of PMD Act, relevant regulations and guidelines.
- Thorough knowledge of drug and medical device development process.
- Very good communication and problem solution skill among cross-functional team.
- Ability to communicate reading, writing, and speaking in English is strongly preferred. (Target : TOEIC score above 800 )
- Bachelor's Degree in Science or related discipline
- Knowledge of relevant in Quality Assurance in pharma industry is plus.
- Strong Communication skill with external parties.
- 給与
- 1000 - 1200 万円
- 勤務地
- 東京