Jobs list of Quality Assurance / Quality Control
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NEWJob number: JN -062025-190248 Posted: 2025-08-04
メガネフレーム 品質管理 リーダー候補
クリエイティブな視点を持って業務に取り組める人材がベストフィット6 - 8.5 million yen Tokyo Industrial Quality Assurance / Quality Control
- Company overview
- Our client is a leading eyewear company renowned for its innovative designs and commitment to high-quality, affordable vision solutions. Headquartered in Tokyo, Japan, it operates over 600 stores worldwide, with a presence in Asia, North America, and Europe, and employs approximately 3,500 professionals.
In Japan, our client is a major force in the eyewear industry, offering a diverse range of stylish and functional products through its extensive network of stores. Its focus on cutting-edge technology and customer satisfaction positions it as a key player in the global market. - Responsibilities
- ３つの基本業務。業務内容：
商品品質管理→企画品質保証＝品質基準管理シーズン企画スケジュールに則って各試験を行い商品企画品質の保証と実着用テストにて「掛け心地」など確認
工場品質管理→本生産品質保証＝バラツキ管理生産工場の品質管理を監査し適正た管理体制が維持されているかの定期監査を実施。
生産された商品の品質保証のために中間検査や最終検査をを実行
中国外生産国については、生産管理体制の構築をおこなう
販売国法規制管理→市場品質保証＝品質基準管理新規出店国に対して法的規制を理解し正しい品質を確保する
お客様の声を聴きながら、お客様満足にむけて品質管理方法を適正なやり方やや体制を柔軟に対応
Emmeline Tang
Industrial & Life Science -
NEWJob number: JN -062025-189787 Posted: 2025-08-01
品質管理室（食料関連)
大手総合商社での食品の安全衛生業務をお任せします。6 - 15 million yen Tokyo Chemical Quality Assurance / Quality Control
- Company overview
- We are a comprehensive trading company with business operations spanning across a wide range of industries. From machinery and aerospace, energy and metal resources, to chemicals and synthetic resins, construction and timber, and consumer goods industries, we are involved in various sectors. Leveraging our global network, we engage in transactions and investments worldwide, catering to diverse needs. Furthermore, we are committed to sustainable business practices and contribute to society through corporate social responsibility initiatives, prioritizing the well-being of local communities and the environment.
- Responsibilities
- 業務内容：
自社トレード事業や投資先事業会社の品質管理支援。
事業投資先により事業内容や管理レベルも異なるため、チーム員を纏めながら、事業会社の改善をリードしていく業務。
Shizuka Tsunashima
Industrial & Life Science -
NEWJob number: JN -042025-186960 Posted: 2025-08-01
Quality Assurance Engineer
Fosters a globally connected, innovation-driven culture6 - 8 million yen Kanagawa Industrial Quality Assurance / Quality Control
- Company overview
- We are the Japan branch of a comprehensive manufacturer in the communications industry. Maintaining an integrated in-house system from development to production, we continue to operate a highly profitable business. Positioned as a crucial hub for technological development and production within our group, over one-third of the new electronic devices developed by our group are created in Japan. We place significant emphasis on research and development and capital investment, consistently allocating a portion of our revenue to these areas to foster a rich development environment. Our advanced technical capabilities span from the development and manufacturing of connectors, and the design and development of precision molds, to the development and design of ultra-high-speed automated robots, all within our company.
- Responsibilities
- Deepen your front-end QA expertise with the Top Component Maker's mass production process!In this role, you'll be at the forefront of ensuring product quality by investigating defects, leading process improvements, and collaborating with manufacturing plants. Enjoy a dynamic working environment with opportunities for professional growth and occasional travel to client sites.
Main responsibilities:
Responding to customer inquiriesInvestigate defective products and identify the cause of failure. Prepare an analysis report based on the results.
If there is a manufacturing defect, we work with the manufacturing plant to limit the lot and create a countermeasure report.
If necessary, visit clients and explain the reports.
In addition, we will use analysis and evaluation equipment to analyze defective products, and we will provide training on how to use it. Factory microscopes (for dimensional measurement), SEM/EDX analysis, insertion/removal testers, contact resistance measuring instruments, etc.
Leading process improvement activitiesIf there are many complaints or process defects, we will work with the manufacturing plant to carry out quality improvement activities.
If necessary, we will visit and audit manufacturing plants and create action plans based on the audit results.
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Duy Pham
Industrial & Life Science -
NEWJob number: JN -072025-191949 Posted: 2025-07-31
【東京】医療機器の品質保証
認証機関での職務経験者必見です!8 - 10 million yen Tokyo Industrial Quality Assurance / Quality Control
- Company overview
- Our client stands as a prominent player in the field of medtech, providing a wide range of offerings including medical equipment, medical imaging processing devices, diagnostic tools, and life science-related equipment. It delivers products and solutions aimed at advancing diagnostics, treatments, and healthcare, operating across the comprehensive spectrum of medical technology and diagnostics.
- Responsibilities
- 各国の医療機器規制要求、ならびに社内のQuality Management Systemを理解し、工場での設計・製造活動への展開・指導
それら変更に対する理解・展開・指導
品質方針の展開・指導
製品開発、生産移管、製造変更管理等でのQMS活動（Milestone、Formal Design Review、各種Review、Operation Mechanism等）において、Global MemberとのReview、Discussion、Facilitation
各国規制当局・認証機関による外部査察・監査への対応
内部監査プラン立案・実施。社内Global memberによる内部監査への対応
不適合発生時における不適合処置・是正処置・予防処置のLeadとFacilitation等
英語使用場面:
海外からの監査、グローバルメンバーとの折衝が発生します
英語使用頻度：最低週1回以上はあります
例：QMS体制を各サイトに共有する、トピックについて共有など
Martin Tsvetkov
Industrial & Life Science -
NEWJob number: JN -052025-188955 Posted: 2025-07-30
Quality Assurance Specialist (Product Quality)
Advance robotic-assisted surgery w/ cutting-edge innovation6.4345 - 9 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is the global technology leader in minimally invasive surgery.
- Responsibilities
- This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality.
Main responsibilities:
Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
Completing quality issues by working with regulatory agencies, customers and related functions.
Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
Involve in implementation of a field action like a recall.
Collaborate with QRC team to maintain Quality Management System.
Work related to product realization (control DMRs and materials for released products etc.)
Operate product release (IQC, labeling instructions, and market release assessment etc.)
Manage non-conforming products (rework, concession, and hold etc.)
Work related to data analysis and CAPA.
Elaine Montes
Industrial & Life Science -
Job number: JN -062025-190369 Posted: 2025-07-28
QMS担当
QMSに関する業務のご経験をお持ちの方必見です5 - 7 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a large industrial manufacturer with various businesses.
- Responsibilities
- メディカル技術センターで開発する製品（能動医療機器、非能動医療機器）に対するQMS業務（業許可含む）【QMSの維持管理に係わる業務】法規制、規格の発行・改訂状況の監視とその対応の進捗管理
文書管理
教育（メディカル事業部門の人員に対してQMSや法改正に伴う変更等を実施）
【医療機器製造業の業態の管理監督に係わる業務】業許可の登録、更新
【監査対応（社内監査年1回、社外認証機関年1回、計2回いずれも対応）】内部監査員としての内部監査を含む
Go Ozawa
Industrial & Life Science -
Job number: JN -072025-191217 Posted: 2025-07-28
【東京】GCP/GVP Quality Specialist
広いネットワーキングやコミュニケーション力を強化できる7 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- ■職務内容：適性に応じて、以下のいずれかの業務を担っていただきます。①QMS業務GCP/GVPに対する包括的なQMSのプロセス/デジタル化戦略を策定し、グローバルレベルでその推進を行う
GCP/GVP領域のQMS戦略を立案・実行し、その効果を評価しながら、継続的な改善を行う
GCP/GVP規制等の最新動向を把握し、QMSの運用を強化するための持続的な改善活動を実施する
委員会やGlobal Process Owner Network等のQMS活動やQAガバナンスを継続的に改善する
チームや部署の目標設定に対し、約束された成果の達成に向けた計画を策定する
②QA業務GCP/GVP監査による国内外規制要件および社内規定の遵守状況の確認に基づくQuality Management System(QMS)改善提案とCAPA Planのレビューを実施する
GCP/GVPの査察対応業務（Inspection Lead）を通じて、規制当局、またはパートナー監査者からの複雑な問合せに対応する
GCP/GVP領域における複雑な問合せに対する規制要件、社内規定に基づいたコンサル業務を実施する
■職種の魅力： 様々なQuality業務担当者とのコラボレーションを通じて幅広いQMS/QA業務への理解が深まり、継続的改善に生かすことができる
同じ組織でPV領域とGCP領域のQMS/QA活動を実施しているため、GxP俯瞰的な高い視座に立った活動ができる
グローバルなフィールドで活動することにより、先進的な欧米の薬事規制対応力を向上させることができる
社内外・国内外の顧客やステークホルダーとの協働により、広いネットワーキングやコミュニケーション力を強化できる
Go Ozawa
Industrial & Life Science -
Job number: JN -072025-191810 Posted: 2025-07-28
Quality Assurance (品質保証)
ヘルスケア業界での品質保証実務のご経験をお持ちの方必見です6 - 9 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- A global medical technology company, we develop and manufacture innovative non-invasive patient monitoring technologies, including medical devices and a broad range of sensors.
- Responsibilities
- アシスタントマネージャーもしくはシニアスペシャリストのポジションにて、同社製品の安全性と有効性を保証する役割を担っていただきます。職務詳細:
品質保証および管理システムの実施および運用の検証
会社の品質方針が十分に理解、実施、運用、維持されていることの検証
品質システム全般の実施と継続的な改善
品質管理手順の見直し、更新、配布の管理
品質システムに関する社内要員の適切な訓練
顧客満足度の監視／測定、および弱点分野の改善／是正措置の実施
欠陥や不具合の速やかな調査、是正措置および予防措置の提案・実施
Elaine Montes
Industrial & Life Science -
Job number: JN -032025-185313 Posted: 2025-07-25
QAエンジニア
医薬品・医療機器製造工場における品質部門での業務経験をお持ちの方必見です6.5 - 8 million yen Aichi Medical Device Quality Assurance / Quality Control
- Company overview
- We are the Japanese subsidiary of a healthcare product manufacturing and distribution company founded in the United States. Recognized as a workplace-friendly company in the healthcare industry, we offer a wide range of product lines. We supply various products necessary for surgeries and examinations to hospitals, care facilities, and other healthcare settings. The disposable nature of our products contributes to infection prevention and operational efficiency. With a focus on disposable surgical products, we provide a diverse range of offerings to meet the needs of our customers.
- Responsibilities
- （1）製造所における薬機法・ISO13485等の要求事項に基づく品質マネジメントシステム全般の管理および維持改善（2）リスクベースドに基づく品質傾向の分析、品質確保のための改善等の立案・実施（3）プロセスバリデーション業務および関連プロジェクト業務の管理・実施（4）サプライヤー、アウトソース先の管理（5）社内外監査対応
Risa Harada
Industrial & Life Science -
Job number: JN -072024-34281 Posted: 2025-07-25
品質保証/QA
ライフサイエンス市場及び製品に関する幅広い業務知見をお持ちの方必見です。7.3 - 8.8 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a global provider of diagnostic, medical device, healthcare IT, and life science products and services for a wide range of customers, from research to diagnosis, treatment, and prevention. We are committed to quality and innovation, utilizing the latest science and technology. Our products and services contribute to accurate diagnosis, treatment, and health care in the medical field. We also value collaboration with research institutes and medical institutions to contribute to the advancement of medicine and human health. Our business model is sustainability oriented and socially responsible.
- Responsibilities
- グローバルでトップクラスシェアを有するバイオメディカ事業部の品質保証部では、今後グローバルオペレーションの強化（海外の販売会社・工場・購入先とのコミュニケーション強化）、新規事業や新規製品のQMS確立、長期的な高精度品質保証を継続的に実現するため、品質監査主担当（リーダー候補）ポジションを募集します。
業務内容：
内部品質監査、購入先品質監査、外部委託先品質監査、及び監査結果のまとめと報告、是正確認
工場、外部委託先工程の品質向上に向けた支援活動
購入先の品質向上に向けた支援活動
品質マネジメントシステム運営のサポート
Takahisa Hitotsumatsu
Industrial & Life Science -
Job number: JN -072024-32995 Posted: 2025-07-25
品質保証担当者
コロナ禍で身近になったあの製品がマーケットシェア上位の外資系企業8 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- This company is a global manufacturing company specializing in hand care and sanitizing products.
- Responsibilities
- 業務内容：
安全管理に関する体制整備
品質保証体制整備
品質保証実務
品質及び生産性向上・コスト削減に向けた活動
各種試験・テストの実施
組織のマネジメント
製造所の管理（監査含む）
国内生産化の推進
Takahisa Hitotsumatsu
Industrial & Life Science -
Job number: JN -062025-190269 Posted: 2025-07-25
プログラム医療機器の品質保証
医療機器の品質管理・品質保証業務のご経験をお持ちの方必見です10 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is undertakes genetic testing services, cancer genome profiling tests, genetic tests, and other analyses.
- Responsibilities
- プログラム医療機器における品質保証業務、及びチームのマネジメント業務をお任せします。〈具体的な業務〉新商品(サービス)の品質確認
医療機器の上市後品質管理及び遺伝子検査ラボの品質管理の監視・監督
QMS省令(ISO13485)に適合した品証業務
苦情処理プロセスの管理・推進
Takahisa Hitotsumatsu
Industrial & Life Science -
Job number: JN -012025-183452 Posted: 2025-07-25
GVP Senior Specialist/ Specialist
GVP/PVの経験（製薬・医療機器不問）が活かせます6 - 8.5 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.
- Responsibilities
- 【未経験チャレンジ枠もあり◎／トップクラスシェア製品の安全性管理を通じて医療の安全に貢献】
■職務内容：
医療機器（TAVI：経カテーテル大動脈弁置換術）の安全性情報に関する安全管理業務全般国内/Globalのデータベースへの情報入力（英語/日本語）：安全性情報の英訳、GVP業務
行政報告書の電子申請業務：Web による申請業務
医療現場担当者（営業他）への各種問い合わせ
GVP業務に関するGlobalの関係部門との調整
行政、業界、学会等への安全性に関する対応
各種報告書、データ作成
将来的に、以下業務に関わっていただく可能性もございます。医療機器添付文書に関する他部門との協業
GVP教育訓練の資料作成、運用
内部・外部監査の事前準備、監査員への応答
発生事象のデータ集計、トレンド分析、関連部門への提供と説明
GVP業務に関連したソフトウェアの検証試験、管理
■ポジションの魅力：
国内外でトップクラスシェアの製品の安全管理業務に携わるため、その分責任も社会的意義も大きい
承認拡大や新製品導入が継続的にあり、最新の医療技術を学び続けられる
チームメンバーや海外拠点の社員が協力的かつ穏やかで、中途入社者も安心して仲間に入って働ける雰囲気
業務の幅を拡げられるチャンスが多い
英語でのトレーニング受講や会議の参加、（ゆくゆくは海外出張）を通じて語学スキルを向上できる
#poweredjob1
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072025-191544 Posted: 2025-07-25
Quality Control Supervisor
Seeks QC Supervisor @ JOC for compliance, training & release9 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- First class medical devices manufacturing and sales business. Medical device manufacturing. Highly managed medical equipment sales and rental business.
- Responsibilities
- Main responsibilities:
Supervises QC activities at JOC
Assures that quality control activities are performed in accordance to current procedures and specifications.
Assures QC personnel have appropriate output to meet inventory and patient needs; coordinates QC resources as needed.
Trains and retrains QC inspectors as needed.
Supports the release of medical products to be used by customers.
Identifies non-conforming materials and initiates NCMRs/service call.
Perform SAP-related transaction to support release of product.
Propose NCMR dispositions to facilitate workflow.
Redacts and reviews documents and records to ensure accuracy and conformance to Good Documentation Practices (GDP).
Accurately documents incoming, in-process, and final inspection data for trending.
Collaborates and communicates with key stakeholders in Planning, Operations and Service.
Liaison between Japan and Global regions for alignment on inspection process and PM for NPI.
Perform validation of equipment used in QC activities.
Completes and delegates work according to established priorities, policies, practices and procedures to assure deliverables meet requirements
Provides support to the Global Quality Operations Lead with day-to-day quality department responsibilities and meeting quality goals.
業務内容：
JOC (Japan Operation Center)における品質管理（QC）活動を監督する
現行の手順および仕様に従って品質管理業務が実施されていることを保証する
QC 担当者が在庫および患者ニーズに対応できる適切な成果を出せるよう支援し、必要に応じてQC リソースを調整する
必要に応じて QC 検査員の教育・再教育を実施する
当社の顧客が使用する医療製品の出荷判定をサポートする
不適合製品を特定し、不適合製品報告（NCMR/Service call）を開始する
業務効率を促進するために、NCMR の処置（対応案）を提案する
文書および記録の正確性と適切な記録管理（GDP: Good Documentation Practices）への適合を確認・レビューする
受入検査、中間検査、最終検査のデータを正確に記録し、傾向分析に役立てる
生産計画部門、オペレーション部門、修理部門などの主要関係者と協力・連携を図る
日本とグローバル地域との間で、検査プロセスや新製品導入（NPI）の予防保全（PM）に関する整合を図るための窓口となる
QC 活動に使用する機器の Validation を実施する。
既定の優先順位、方針、業務慣行、手順に基づいて業務を遂行・委任し、成果物が要件を満たすよう保証する
日々の品質部門の業務および品質目標の達成に向けて、グローバル品質業務リードを支援する。
Elaine Montes
Industrial & Life Science -
Job number: JN -072025-191527 Posted: 2025-07-25
QMS Manager
Negotiation & coordination w/ overseas product development7 - 15 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a global medical device manufacturer.
- Responsibilities
- 医療機器製造販売業のQMS体制の運用担当者（国内品質業務運営責任者）に加え、下記業務をお願いします安全管理/品質保証業務について、QMS省令に基づいた組織体制の構築
国内QMS責任者として海外生産拠点との折衝・監査・オーディット・登録業務
監督官庁・PMDAとの折衝業務
海外の製造所からのドキュメント情報入手と精査
In addition to being in charge of operating the QMS system for a medical device manufacturer and distributor (domestic quality operations manager), you will also be required to perform the following duties:
Establish an organizational structure based on the QMS Ministerial Ordinance for safety management/quality assurance operations
Negotiations, audits, and registration work with overseas production bases as the domestic QMS manager
Negotiations with supervisory authorities and the PMDA
Acquisition and review of document information from overseas manufacturing sites
Elaine Montes
Industrial & Life Science -
Job number: JN -072024-143827 Posted: 2025-07-25
品質保証 QA
Global Company6 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- 医療機器、再生医療製品等を含む新たなモダリティへの業務展開
新たな技術の導入、技術の進化
サプライチェーンの多様化
グローバル製品（開発品・市販品）の増加
製造委託先、試験委託先ならびに原材料供給業者の増加
そのため、GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務に精通した要員の補充が必要となった。
IND/IMPD、NDA/BLA作成及び推進、国内申請資料作成及び推進、その他CMC薬事にかかわる業務
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-38866 Posted: 2025-07-25
Quality Assurance Senior Manager
Full Remote QA Senior Manager position12 - 15 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- The company is a foreign-affiliated pharmaceutical company.
- Responsibilities
- Provide strong support team management for GQP Head on day-to-day basis
Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS
Perform other duties as assigned such as described below, but are not limited to:
Provide support for regulatory agency inspection readiness and requests
Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
Support business develop
Yui Osone
Industrial & Life Science -
Job number: JN -062025-189182 Posted: 2025-07-25
治験薬（製剤）品質保証
医薬品・医療機器等の企業でのGMP/GQP品質保証業務経験をお持ちの方必見です9 - 11 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 国内外レギュレーションに準拠した治験薬（製剤）の品質保証業務をお任せしていきます。【具体的に】委託先・供給業者監査
（国内のみに限らず海外対応も含む．海外委託先との会議・実地監査）・品質契約（国内のみに限らず海外対応含む．英文品質契約書の締結）の締結変更管理/異常・逸脱対応/苦情対応/回収/自己点検/マネジメントレビュー対応
治験薬製造記録及び分析記録の照査/出荷判定
新薬承認申請資料（CTD及び生データ）の照査
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-137933 Posted: 2025-07-25
QA Manager
QA Manager10 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
- Responsibilities
- Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
Ensure full compliance with applicable regulations in Japan.
Oversee all activities or responsibilities that are delegated to external parties.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-190815 Posted: 2025-07-25
品質保証責任者
品質保証のご経験をお持ちの方必見です7 - 10 million yen Kanagawa Pharmaceutical Quality Assurance / Quality Control
- Company overview
- -
- Responsibilities
- 同社製品の上市に向かって品質保証業務をリードしていただきます。GMP／GCTP関連をはじめ、社内のルール、手順書のブラッシュアップが必要な状況です。ルーチンワークだけではなく、現状に即してアイデアを出して頂くことが必要となります。PMDAの査察対応など上市を目指す上で重要な役割も発生いたします。担当業務:
各品質保証業務の責任者として確認やレビューなどを行っていただきます。製造所における GCTP／GMPの運用管理、改善業務
製造プロセス変更等の変更管理
外部業者の管理、監査※
自己点検（製造現場の社内監査など）
文書管理、手順のチェック見直し
逸脱管理、品質リスクマネジメント
医薬品、治験薬の製造所出荷判定
社内役職員の教育訓練
CAPA（是正措置、予防措置）対応
コンピュータシステムバリデーション
Data Integrity 管理
PMDAやFDA等の監査対応
※将来的に海外の委託先の監査を行う可能性があります。
Martin Tsvetkov
Industrial & Life Science