Overview

• 3-4日のリモート勤務可能

• QMS関連のコンサルティング業務を担当する機会があります。

To understand requirements from QMS/PMD Act., and support QA Senior Manager who drive forward proper Quality Management system operation and maintenance Create documents of QMS,FMR and MAH license related application under supervision of QA senior manager. Remote work available (3–4 days per week) If your interests and skills are a good match, you may have the opportunity to undertake QMS-related consulting work.

Responsibilities and Duties

部門長の以下の活動をサポートする。

• • 3PLの国内製造所における品質項目の確定、品質、製造/出荷管理

• • 不適合品の管理を含む、出荷、配送の管理

• • 英文苦情調査報告書の和訳、国内顧客向け苦情報告書の作成（外国製造所への問い合わせ対応を含む）

その他の下記QMS文書・記録等の作成（英文和訳、和文英訳含む）とファイリング、Eメール・電話対応（日英）

• • 変更管理

• • SOPおよび記録の管理

• • 製品標準書の作成、更新

• • ライセンスの保持者ならびに国内製造所との品質に関する契約書の作成、更新

• • 是正措置および予防措置の管理

• • ライセンス保持者の監視を含む購買管理

• • 従業員の教育・訓練管理

• • 回収：随時

• • 製造販売業許可の取得：随時

• • PMDAや登録認証機関などの認証機関の監査対応

Job Description

• • クライアント（ライセンス保持者）に対する、QMS監査、FMRの説明およびQMS・FMR申請書・変更届の作成

Support QA senior manager for the following activities

• • Market Release and Distribution Control including management of non-conformity

• • Oversight of Final release,Quality Control and Manufacturing Control, including establishment /update of quality criteria in Japan 3PL manufacturers

• • Translate English Complaint investigation report and prepare Customer letter in Japanese （Including correspondence with overseas manufacturers）

Other QMS document / record preparation etc（Including English-to-Japanese translation）and archiving, Japanese-to-English translation, e-mail, telephone correspondence in English and Japanese

• • Change Control

• • QMS Document (SOPs) and Records Control

• • Establishment/Update of J-DMR

• • Establishment/Update of Quality agreement with License holders and domestic manufacturers

• • Management of Corrective Action and Preventive Action

• • Purchase control including oversight of License Holders

• • Training to dedicated employees

• • Recalls Control: Ad-Hoc

• • Application of MAH license approval and Distributor license: Ad-Hoc

• • Onsite audit handling (PMDA, Notified body BSI and customer audit)

• • Create application of QMS inspection and FMR document, including explanation of QMS/FMR to the customers (license holders) and other QMS related documents

Required Knowledge, Skills, and Experience

• **Education:**大学卒もしくは高等専門学校卒業

• Bachelor’s degree or graduation from a technical college

• Certification/Licensure: 特になしNot applicable.

• Experience: 2年以上の関連する分野での業務経験 (品質、製造、薬事部門。医療機器及び電気製品を含む)

• Minimum two years of professional experience in related field（Quality, Manufacturing, Regulatory department in Medical device or Electrical product field）

Other: 英語でのスピーキング（ビジネスレベル）及び英語力TOEIC700以上（読み、書き、e-mailでのコミュニケーション）

• PCスキル（Word, Excel, Power Point）

Job Description

English: Speaking business level, Business (TOEIC 700+) , Reading / Writing, E-mail Communication Translation simple sentence both J -> E and E -> J, w/o dictionary/tool Smooth communication with internal/external customers PC Skill general: Word, Excel, Power point

Supervisory responsibilities

• 特になしNot applicable.

Work environment

• • 強力なチームスピリットとともにコラボレーションを図ること

• • 同僚、部下、部門長と良好な関係を構築すること

• • ハラスメントのない職場環境を確保すること

• • クライアントおよび販売業者に関連した種々の問題に対し、薬機法、QMS省令およびGVP省令に適合するよう、部門長に対し、正確、迅速、正直な報告、相談

• • 週3-4日のリモート勤務可能

• • ご本人の希望とスキルがマッチした場合、QMS関連のコンサルティング業務を担当する機会があります。

• • Collaborative with a strong team spirit.

• • Interaction with peers, subordinates, and managers.

• • Entitled to a work environment that is free from harassment.

• • Need accuracy, quickness and honesty in reporting/consulting to QA senior manager in order to perform operation compliant to JPAL, QMS, GVP ordinance and other issues related to customers (license holders) /distributors handling.

• Remote work available (3–4 days per week)

• If your interests and skills are a good match, you may have the opportunity to undertake QMS-related consulting work.

Travel required

• 外勤（トレーニング受講を目的とした海外製造所への出張を含む）

• Occasional travel is required including visiting overseas manufacturer to receive trainings

Affirmative Action/EEO statement

弊社はダイバーシティを確保し、従業員に公平な機会を提供する。すべての雇用は資格、調書、ビジネスニーズに基づいて決定される。 We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.

Other duties

本職務記述書は担当業務の全てをカバーすることを目的とし、作成されておらず、本ポジションにおける包括的な活動、義務、責任を記述したものとなる。活動、義務、責任は周知のあるなしにかかわらず、変更する場合がある。 Job Description Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.