その他、技術・専門職系(メディカル)
Quality Assurance Leader
その他、技術・専門職系(メディカル)

Quality Assurance Leader
の転職・求人情報はすでに掲載終了しております。(掲載期間10月4日~10月31日)

※ 掲載時の募集要項はページ下部よりご確認いただけます。
他の方はこんな求人もチェックしています
ミドルの転職では、各専門分野のコンサルタント4723が紹介する181019の転職情報を掲載しています。
希望条件で探す
職種、勤務地、年収などを組み合わせて探すことができます。
掲載時の募集要項掲載期間:2022/10/04 ~ 2022/10/31)
その他、技術・専門職系(メディカル)

Quality Assurance Leader

外資系企業 海外展開あり(日系グローバル企業) 大手企業 管理職・マネジャー 海外折衝 土日祝休み

募集要項

募集背景
<About the position>

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has working knowledge of competition and the factors that differentiate them in the market.

The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance) with regards to the area of responsibility and specialization in support of continuous business and organizational growth.
仕事内容
The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations
<Responsibilities>

* Own the QA process under, e.g., Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, etc.
* Function as Hinseki to support the Sanyaku organization within the Japan office
* Lead the preparation and execution of Quality Management Reviews for the region
* Manage quality evaluation of warehouse operations, manufacturing sites, and external laboratories
* Provide support to routine activities, projects, development and training relevant to area of expertise where required
* Support continuous improvement activities regarding areas of responsibility
* Engaging assessment regulatory impact on product and manufacturing processes.
* Engaging site inspections, preparing audits observations response as necessary
* Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters
応募資格
必須
Leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance)
歓迎
・Strong oral and written communication skills. Strong interpersonal and leadership skills. Established project management skills
・Pharmacist license
・Experience being in Sokatsu and Hinseki roles
・Working experience in MNC pharmaceutical/medical device/healthcare product organizations
・Experiences with CAPA systems and experiences applying regulations (GMP, Good Distribution Practices)
フィットする人物像
<Required Qualifications>

* B.S. Degree in bioscience, chemistry, pharmaceutical, business or technical field
* 7 years of QA experience in Pharma/Medical device or other regulated industry in total, at least 3-5 years of QA experience in a pharmaceutical and/or medical device manufacturing environment
* Proficient with MS software
* Proficient with eQMS and eDMS systems
* Ability to work independently in a fast-paced team environment with little supervision
* Ability to communicate effectively in Japanese and basic level of English
* Strong managerial, people guidance, project management and time-management skills

<Desired Characteristics>

* Strong oral and written communication skills. Strong interpersonal and leadership skills. Established project management skills
* Pharmacist license
* Experience being in Sokatsu and Hinseki roles
* Working experience in MNC pharmaceutical/medical device/healthcare product organizations
* Experiences with CAPA systems and experiences applying regulations (GMP, Good Distribution Practices)
* QC testing experience for sterile products
雇用形態
Permanent
勤務地
Tokyo
年収・給与
JPY8,000,000.00 - JPY10,000,000.00 per annum + competitive

会社概要

社名
非公開
事業内容・会社の特長
<About the company>

A leading global innovator at Medical Devices, Image Diagnostics, and digital solutions that continues to improve the workflow of medical professionals by developing best class Medical Devices and Pharmaceutical products, while delivering data analyzing services and applications
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Q.
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A.
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また、より良い待遇条件で転職が決まるように条件面での交渉をしてもらえます。
Quality Assurance Leaderの転職・求人情報 16782921。プロのコンサルタントがサポートする日本最大級のキャリア転職情報サイト。年収800万円以上の高年収、管理職、スペシャリストの求人、非公開求人スカウトも多数。