Sr. QA Specialist, Global Pharmaceuticals company, ~11M,Saitama | Michael Page Japan の求人詳細

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キービジュアル キービジュアル
更新日 2018-07-07
掲載開始日 2018-07-06

Sr. QA Specialist, Global Pharmaceuticals company, ~11M,Saitama

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  • ★★★★ マネージャーレベル
この求人の
取扱い会社
人材紹介
Michael Page Japan
企業名 One of the largest pharmaceutical companies in the world.
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 品質管理/保証
業種 製薬メーカー
勤務地 アジア 日本 埼玉県

仕事内容 * Receipt, handling, storage, and disposition of products and components
* Corrective and preventive actions (CAPA) investigation, management and approval


Description

* Ensure that adequate controls and procedures are in place for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labelling, drug substances incl. intermediates and drug products incl. intermediates. Provide quality oversight for such activities.
* Ensure that adequate processes and procedures are in place and followed for batch record review.
* Ensure that product returned for salvage and product directorate to improper storage conditions during shipping is properly assessed and its disposition decided.
* Authorize any exception based processing of materials (e.g., conditional, reprocessing, reworking, repackaging) and any transfer of unreleased materials within company requirements and procedures.
* Oversee, manage and approve corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labelling, drug substances and drug products and associated facilities.
* Perform or review Annual Product Reviews/Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
* Provide Quality Oversight for all suppliers managed by the site including signing of local Quality Agreements and change management in case of supplier changes initiated by the site.


Profile

* M.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering are preferable.
* Strong experiences in pharmaceuticals industry especially in Quality department.
* Strong verbal, written, presentation and interpersonal communication skills (English and Japanese)
* Knowledge of GMPs, GQP, SOPs are preferable.


Job Offer

8M-11M


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)
* One of the largest pharmaceutical companies in the world.
* Company provides the innovative medicines, vaccines, and animal health products
応募条件 *M.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering are preferable.
*Strong experiences in pharmaceuticals industry especially in Quality department.
*Strong verbal, written, presentation and interpersonal communication skills (English and Japanese)
*Knowledge of GMPs, GQP, SOPs are preferable.
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   
休日 8:45〜17:30
No Holiday Working
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Sr. QA Specialist, Global Pharmaceuticals company, ~11M,Saitama

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