GQPシニアスペシャリスト

Job Details

<求人タイトル>

16685 GQPシニアスペシャリスト

<職務内容>

・Arrange quality agreements between manufacturing sites where approved products are manufactured.
・Enforce periodical on-site auditing to the manufacturer and confirm if proper product/quality control is enforced. Also, if audit resulted for remedy, propose CAPA
to QAS.
・Analyze and evaluate product quality and propose and enforce quality improvement counterplan.
・Enforce preventive measures for deviation reoccurrence.
・Quickly investigate the cause of the complaint for the product quality and prepare written report. Visit customers if necessary and explain the report.
・By evaluating and confirming the manufacturing change method and the testing
change method by following the change control SOP, enforce the suitable change
management.
・File documents following Pharmaceutical and Medical Devices law, GQP ministerial order and the company’s SOP and train related departments on GQP following the yearly schedule.
・Take control of the manufacturing information for variance on manufacturing method, testing item, and other necessary written information in the manufacturing approval document.

<応募要件>

・Knowledge of PMD Act., GQP/GMP ministerial ordinances, and related regulations.
・Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
・Knowledge of accreditation/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP compliance inspection etc

Behavior Characteristics/行動特性:
・Communication skill for achieving good relationship with authorities and connected departments.
・Strong leadership skill to perform cross functional tasks.
・Logical thinking to make regulatory strategy. (Technical Skill/テクニカルスキル)
・Managing and supervising skill for appropriate manufacturing and quality control of the manufacturing sites (API site, Formulation site, etc.) listed in approved files.
・Capabilities of analyzing the management results of manufacturing sites, make
instructions for improvement if necessary.
・GQP or GMP operations (Desirable) Regulatory application for manufacturing control and quality control operations
・Quality control testing operation at the manufacturing sites, drug production or
packaging related operations.
・B.S. or M.S. of Science
・Pharmacist license desirable.
・Communication skills in English via email with overseas in charge person.
・Understand English documents

<会社概要>

オンコロジー・ヘマトロジー・再生医療領域等に注力する大手外資系スペシャリティファーマです。再生医療を含めて今後も更なるビジネスの拡大が見込まれている企業になります。スピード感にあふれ意思決定がとても早く、新しいことにどんどんチャレンジをしていきたい方にとって、とても魅力的な会社です。

<注目ポイント>

GQPの主任レベルのポジションとなります!GQP省令に基づいた業務(教育訓練、苦情対応、文書管理)やGMP適合性調査 などを担っていただきます。ご興味がございましたら、是非お早めにお問い合わせください!

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company