品質保証担当者／Quality Assurance Specialist

GMP, GQP, GDP, QMS, GCTP）の専門家を募集する：

QMSの維持・強化

CMOの管理強化

Background to Recruitment :

We are looking for QA specialists who have high expertize for GMP, GQP, GDP, QMS, and GCTP according to following reasons :

• Increase of the number of medicinal products, physical devices, regenerative product for development / commercial which needs global QA standard
• To maintain / enhance QMS operations for SaMD for developmenmt and commercial phase
• To enhance QA oversight of CMOs in domestic and overseas
• To improve relationship with Roche and / or overseas' licensee

PQS要件の運用推進業務

GMP / GDP業務の管理監督

SaMDの開発・製造販売に関わるQMS業務

Description of Work :

Corporate Quality Assurance operations in compliance with GQP, QMS, GMP / GDP, GCTP requirements.

Auditing manufacturing and testing sites, warehouse, distributors and suppliers

Preparation and conclusion of quality agreement and liaison with manufacturing and testing sites, sales partners, product licensees, warehouses, distributors and suppliers

Complaint handling and support of an effective complaints management process

Project management and / or commumication with Roche as to product quality issues and quality assurance

Maintainance and improvement of quality systems

Support of the implementation and maintenance of Pharmaceutical Quality System in line with global standards

Management and support of GMP / GDP operations in overseas affiliates

QMS operations related to SaMD in development and commercial phase

Position Features :

In addition to conventional chemical and biopharmaceutical products, new products and services such as genome profiling, medium-molecular-weight products, and regenerative medicine products have been developed on a fast track. Although quality assurance in areas that cannot be covered by conventional regulations is challenging, it is rewarding to solve various issues by cooperating with authorities and domestic and overseas partner companies including Roche. 応募資格／Qualifications 求める経験：

GQP / GMP / GDP / GCTP / QMSに関する品質保証業務経験

CMC開発経験、または医療機器設計開発経験

Desired Experience :

Bachelor or master degree in science or engineering

Experience and background in Quality Assurance operations (GQP, GMP / GDP, GCTP, QMS)

Experience of manufacturing and quality control operations in the pharmaceutical industry

Experience of CMC development for medicinal products and design development of medical devices (AI, SaMD, etc…)

GMP / GDP / GCTP(国内、グローバル)に関する知識

GQP / QMSに関する知識、もしくは品質保証に関する知識

Desired Skills :

Knowledge of GMP, GDP, GCTP

Knowledge of GQP, QMS, PQS or quality assurance

Desired Competencies :

To involve stakeholders to find the best solution even for difficult issues

To set challenging goals and commit to execution with ownership and responsibility

To gain and keep good relationships with partner companies, peers and management through open and fair communication

TOEIC 730点以上）

Desired Qualification：

Good level of written and spoken English 待遇／Salary & Benefits 労働条件の通知は電子ファイルによって行います。

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.