GQP＆QMS Specialist

Company Overview
【糖尿病領域シェアNo.1】定着率◎/ヨーロッパ系製薬メーカー

Job Description
Objectives:
- Establishment and maintenance of GQP/QMS system, and confirmation of GMP/QMS compliance in the factories manufacturing the products marketed in Japan
- Adequate handling of product quality information (including customer complaints), for risk management (to reduce potential recall situations) as well as for penetration of optimal use information/customer satisfaction
- Management of overseas factories’ affairs (accreditation maintenance and coordination for GMP/QMS inspection of PMDA and third parties)
- Quality assurance of product storage and distribution


Main Tasks:
1) Execution of activities for GQP/QMS-related requirements and quality of products assigned to team and group
2) Penetration of the optimal use in the market – in some cases, through the project organization
3) Execution of activities related to the regulations for overseas factories assigned to the team and group
4) Other duties such as the role in GQP organization
5) Other accountabilities: Responsibility of Specialist
- Support the group manager/department director, for establishment and achievement of Dept.’s BSC, especially about GQP/QMS compliance.
- For GQP/QMS compliance, couch/advise appropriately to the members of Dept. (disregarding the group)
- Coach daily the team member, and manage the teamwork.
- Keeping of good communication between department and global branches/HQ

Requirements
- Experience of Product Quality Assurance tasks
- Knowledge on company products (specifications, manufacturing process outline, etc.)
- Special Knowledge on GQP/GMP/QMS requirements
- Knowledge on company-specific quality system, especially audit & inspection, review system, etc.

Additional Job Information
Entitlements depend on experience level

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