品質コンプライアンスリード

Job Details

<求人タイトル>

16863 品質コンプライアンスリード

<職務内容>

・Support Quality Assurance Supervisor for the product release to market by the proper evaluation for production control and quality control.
・Plan and execute the CAPAs for quality improvements and deviations by analyzing the information related to the product quality.
・Execute following tasks appropriately: Evaluate and confirm the changes the manufacturing processes and the test methods; Evaluate and handle the deviations during manufacturing; At product recall, prepare and file the reports to the authority and records/documents related; Appropriately manage to fulfil the requirements of Pharmaceutical & Medical Device Act. and other related regulations.
・Manage not to occur discrepancies between the contents in the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing site. Create of FMA application and maintain it.
・Create of GMP/GCTP inspection application and response to PMDA queries.
・Coordinate GMP/GCTP on-site Inspection by Health Authority.
・Generate labels for commercial product in accordance with Pharmaceutical & Medical Device Act.
・Build and maintain a close relationship of trust with global quality, and build and maintain processes aligned with the global quality management system.
・Share knowledge and provide guidance to the members.

<Experience Requirements>
・More than 10 years pharmaceutical industry with more than 5 years in a quality
control and/or quality assurance experience.
<Key Competency Requirements>
Knowledge:
・Knowledge of PMD Act., GQP/GMP/GCTP 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/GCTP compliance inspection etc.
Skill:
(Behavior Characteristics)
・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)
・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.
・Skill to negotiate with PMDA officer on regulatory application and inquires
Language skills:
・Communication skills in English via email and at meetings with overseas in charge person.

<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。働きやすい環境も整っており、コアタイムなしのスーパーフレックス制度、在宅勤務制度もございます。

<注目ポイント>

当局及び顧客からのGMP監査/査察のご対応をいただく品質コンプライアンスリード(シニアマネージャーレベル)の募集です!国内外の製造所とのコミュニケーションがあるため、英語を使うチャンスがありご自身の大きな成長にもつながります。領域経験は問いませんので、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