QA specialist,Global Pharmaceuticals company,~10M, Tokyo | Michael Page Japan の求人詳細

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更新日 2018-07-14
掲載開始日 2018-07-13

QA specialist,Global Pharmaceuticals company,~10M, Tokyo

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取扱い会社
人材紹介
Michael Page Japan
企業名 Global Pharmaceuticals company
職種
Michael Page Japan
機械(自動車/プラント/精密機器) - 品質管理
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 * To ensure that all products or materials supplied to company from suppliers are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines.
* Responsible for supporting total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager.


Description

* Reports to the Quality Lead for Japan and a member of the Quality External Manufacturing team. Receives guidance and direction from the Quality Lead and may be required to operate independently. Keeps the Quality Lead informed on the status of operations and when challenges, opportunities and/or issues arise.
* Assures that the partner operates within the agreed upon GMP/GQP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement.
* Supports audit plans and effective execution of subsequent remediation by the partner; may also perform separate audits
* Conducts regular site visits to support training and coaching to initiate quality improvements within the partners' Operations where necessary.


Profile

* Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent) Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality
* Control including solid knowledge of global GMP and regulatory requirements ,GQP.
* Must have English language capability
* Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
* Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues


Job Offer

6M-9M +10% performance Bonus


To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Bon Siripairoj on +813 6832 8985.
企業について
(社風など)
* A leading global bio-pharmaceutical company.
* Their products are well-known in Japan Market.
応募条件 *Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent) Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality
*Control including solid knowledge of global GMP and regulatory requirements ,GQP.
*Must have English language capability
*Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
*Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
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 経験と能力に基づく   
給与に関する説明 10% performance bonus
休日 8:30~17:15
Flextime + 1 day per week for work at home
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QA specialist,Global Pharmaceuticals company,~10M, Tokyo

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