薬事監査担当者

Job Information

Job ID: 78415
Job Title: 薬事監査担当者
Company Name: Way Simmons Partnership
Job Type: Full-time
Division: 研究開発本部　薬事監査部
Location: Tokyo - 23 Wards
Salary: 8 million yen ~ 12 million yen
Date Refreshed: September 10th, 2008 12:18

General Requirements

Minimum Experience Level: Over 3 years
Minimum English Level: Basic
Minimum Japanese Level: Native
Minimum Education Level: Bachelor's Degree
Visa Status: Japanese national or permission to work in Japan required

Job Description

職務内容

・ GCP監査業務－臨床試験が「医薬品の臨床試験の実施基準に関する省令(ＧＣＰ)」、「薬事法」、「治験実施計画書」、「標準業務手順書（SOP）」などを遵守して実施されているか否かを評価
・内部監査－Globalの品質ポリシーと薬事法に従って卸売一般販売業務が適切に実施されていることを評価する　（出張有）　
・ SOP作成業務

Required Skills

希望条件（必須条件）

・理系のバックグラウンド（薬剤師の方尚可）
・ GCP監査業務の経験2年以上またはGCPに基づいた臨床試験関連の業務５年以上
・ GMP（製造管理及び品質管理）／GQP（医療機器の品質管理）／GVP（製造販売後安全管理）／NDA（新薬承認申請）の知識

Company Description

Way Simmons Partnership has offices in Tokyo, Hong Kong and Singapore and provides contingency, advertised and search solutions across the commerce and industry sector. Our recruitment business is categorised as specialist/professional. With many years of experience in search and selection our team of expert recruitment consultants has experience in the following areas:

Executive & Management
Accounting & Finance
Human Resources
Marketing & Sales
Executive Support

We act for Multinational Companies (MNCs), Small to Medium Enterprises (SMEs) and locally grown diversified businesses and employers of choice who understand the value of working in partnership with a totally focused approach to human resource solutions.

All our consultants are able to rapidly understand their clients’ hiring requirements whilst developing a strong relationship of trust with their candidates. Our team prides itself on carrying out their work with the utmost confidentially and integrity and for candidates, there is no charge for the services that we provide.

Way Simmons Partnership is a division of Legal Futures Japan K.K.

Our recruitment business is categorized as specialist/professional and our placements are limited to Japan only. Our service is free of charge. We will apply and follow the laws and principles of all relevant legislation and maintain data privacy at all times. Please refer to www.legalfutures.com to view our Privacy Policy. The person handling personal information is our license holder Matt Anderson who will also handle any complaints.

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