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薬事本部 QA Specialist
年収：800万 ～ 1000万
採用企業案件
アッヴィ合同会社
-
- 会社規模501-5000人
- その他
| 部署・役職名 | 薬事本部 QA Specialist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Purpose: The QA Specialist is responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process, or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements. Responsibilities: ・Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products. ・Perform under own manager’s supervision in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze, and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective. ・Partner, coordinate, and support activities related to product actions in the affiliate. ・Participate in training and education programs for various aspects of quality assurance. ・Responsible for project teams in planning, preparation, review and approval of quality documentation. ・Coordinate and investigate quality events such as deviations, nonconformances, product complaints and corresponding action plans including decisions. ・Perform assessments to determine compliance to processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. ・Participate in and deliver training and education programs for various aspects of quality assurance. ・Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. ・Manage GMP inspection by PMDA (NDA, PCA and periodical) and Foreign Manufacturer Accreditation (FMA) with collaboration of manufacturing site and AbbVie’s regulatory department. ・Manage GMP inspection by PMDA (NDA, PCA and periodical) with collaboration of manufacturing site and AbbVie’s regulatory department. ・At introduction of a new product or change of an existing product in Japan, facilitate technology transfer such as test method and/or manufacturing method to local test/manufacturing sites, closely cooperating with relevant functions such as global science and technology and/or QA ・Manage change plans for local actions including local SOP management. Assist with local relabeling and complaint handling. ・Participate in / coordinate special project assignments as determined by GQP manager. |
| 労働条件 |
契約期間：期間の定めなし 試⽤期間：あり（3カ⽉） 就業時間：8:45〜17:30（休憩1時間）※フレックスタイム制（コアタイムなし） 休⽇：⼟⽇、祝⽇ 残業：あり 社会保険：健康保険、厚⽣年⾦、労災保険、雇⽤保険 受動喫煙防⽌措置：敷地内禁煙 |
| 応募資格 |
【必須（MUST）】 Qualifications:・Bachelor’s degree in chemistry, Pharmacy, Biology, other technical / scientific area. ・3+ years’ experience in quality assurance, operations, regulatory or relevant experience. Experience at manufacturing site is preferred. ・Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations. ・Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations. ・Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products. ・Strong written and oral communication skills. Proficiency in English. ・Excellent interpersonal skills. ・Strong computer skills and knowledge of enterprise systems such as TrackWise. ・Strong influencing, motivational, interpersonal and relationship building skills at all levels. ・Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded. ・Negotiation skills, effective collaboration and ability to anticipate needs and requirements. Runs small project to deliver tactical results. |
| アピールポイント | フレックスタイム |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/08/30 |
| 求人番号 | 3824873 |
採用企業情報
- アッヴィ合同会社
-
- 会社規模501-5000人
- その他
-
会社概要
【代表者】ジェームス・フェリシアーノ
【本社所在地】東京都港区芝浦3丁目1-21
【事業内容】バイオ医薬品企業
【当社について】
アッヴィは、米国に本社を置く、グローバルな研究開発型のバイオ医薬品企業です。
現在、世界では世界70カ国以上で約5万人、日本においては、1,800人を超える社員がアッヴィで働いています。(2023年12月現在)
設立以来、ゆるぎないコミットメントと自信を持って研究開発に取り組んできました。また、さまざまな課題に挑むためには継続的な投資が必要です。アッヴィは設立以来、新薬の研究開発に約500億ドルを投じています。新しい医薬品や治療法を生み出すために、まだ誰も手をつけたことのない難しい領域に挑み、患者さん、社会、科学にポジティブなインパクトをもたらすことを目指しています。
患者さん、そのご家族、地域社会、そして働く私たち自身を心から大切にし、最高水準の品質、コンプライアンス、安全性、業績を追求し、いつも正しい行動に努めています。世界中のどの国においても、アッヴィの社員は多様な視点やバックグラウンドを受け入れ、それぞれの立場を尊重し皆が平等に向き合います。それが、最良の結果につながると信じているからです。
これからも、医薬品の提供にとどまらず、人々の健康と健全な事業への持続可能なソリューションの提供に貢献していきます。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です