QA Associate Director [GQP]

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募集要項

会社概要

同社はアメリカを拠点とする親会社を持つ大手ライフサイエンス企業です。主に医薬品やワクチンの研究開発、輸入、製造、販売を事業として展開しています。人々の健康を守り、豊かな人生を築く手助けをすることで、同社の使命・目標に向かって日々奮闘し、日本の満たされていない医療ニーズにいち早く応えてゆきます。さらに、さまざまなプログラムやパートナーシップを通じ医薬品を必要とする人々への製品寄付や供給を行い、医薬品へのアクセスを推進する活動に積極的に取り組んでいます。

業務内容

This position will be responsible for the General Manufacturing and Sales Manager under the Pharmaceuticals and Medical Devices Act and the Quality Assurance Manager under the GQP Ministerial Ordinance.
Main responsibilities:

• You will be responsible for quality assurance on our leadership team and will work with the Pharmaceutical Safety Manager to ensure ongoing compliance by making recommendations regarding product safety.
• Based on collated batch records and QC test data conducted in Japan , you will be responsible for continuously monitoring the quality of products imported to Japan and products supplied by contract manufacturers in Japan, and will be responsible for managing the products to ensure their safe shipment.
• You will report safety and quality issues and emergencies to the relevant government agencies in a timely manner.

応募条件

Minimum requirements:

• Bachelor's degree in pharmacy, pharmacist license.
• Native level Japanese, English skills required (reading, writing, speaking)
• Extensive knowledge and experience in GMP and regulatory requirements, expertise and extensive experience in quality systems, quality assurance and quality control
• Strong problem-solving skills and risk management capabilities based on understanding science, data, and regulatory requirements in an evolving environment.
• Expertise in pharmacology, analytical chemistry, microbiology, aseptic processing, cGMP, regulatory affairs, etc.
• Vaccine manufacturing and testing experience
• Ability to demonstrate interpersonal, communication, negotiation, persuasion and leadership skills in a diverse cultural setting, and ability to deal with organizational complexity and ambiguity.
• Exemplary people/team leadership experience including leading and motivating a team.
• Experience establishing performance metrics and holding people accountable for results.
• Experience and problem solving skills in vaccine QC

給与

1800 - 2000 万円

勤務地

東京