Quality Assurance Manager | 株式会社エム・アール・アイ・ジャパン / MRI JAPAN Inc.の求人詳細


キービジュアル キービジュアル
更新日 2018-07-27
掲載開始日 2018-07-26

Quality Assurance Manager

  • ハイクラス
  • ★★★★ マネージャーレベル
株式会社エム・アール・アイ・ジャパン / MRI JAPAN Inc.
企業名 会社名非公開
株式会社エム・アール・アイ・ジャパン / MRI JAPAN Inc.
メディカル/医薬/バイオ/素材/食品 - 生産技術/生産管理
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 •Act as in country contact person for any customers for quality issues and enquiries and communicate with QA Complaint team
•Coordinate the customers’ complaints with QA Complaint team
•Gather necessary information and collect defect products from the customers.
•Submit all the agreed documents to the customers
•Communicate all the QA matters with APAC QA and Japan Commercial
•Review QA matters in the customer meetings
•Implement and maintain training program for Technical Applications Specialist/Field Service Engineer
•Oversight of the suppliers quality system as indicated in the quality agreement signed by the suppliers and the company
•Perform product inspection, rework and shipment release from the suppliers to the customers
•Coordinate with the suppliers and the company for any recall incidents or pharmacovigilance issues
•Assist in any deviation or non-conformities
•Present for all internal and external audits including government inspections and the customers visits
応募条件 【必須(MUST)】
Education: Degree in Pharmacy, Life Science or a related field
Experience/Professional requirement:
•5+ years of quality experience in a commercial environment in a multinational company
•In depth knowledge of ISO regulation requirements as well as local Japanese regulations
•Excellent written and communication skills
•Results oriented, detail-oriented, and ability to multi-tasks
•Analytical and excellent project management skill
•Proficiency in MS Word and Excel.
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 流暢(日本語能力試験1級又はN1)
年収 日本・円 900万円 〜 1000万円   

Quality Assurance Manager