Jobs list of Pharmaceutical & Quality Assurance / Quality Control
-
NEWJob number: Job-00242546 Posted: 2023-10-02
QA/QC Staff Kakegawa, Shizuoka
Shizuoka factory5 - 7 million yen Other Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a contract manufacturer of soft capsules for pharmaceuticals and health foods.
- Responsibilities
- 医薬品・機能性食品ソフトカプセルの品質管理業務を担当します。
原料/製品等のサンプリングと試験の実施
環境試験の実施
SOP の作成と改訂
試験方法の改善 等
Emely Motol
Pharma -
NEWJob number: Job-00247290 Posted: 2023-10-02
QC Staff (Koriyama Factory)
Koriyama Factory4 - 6.6 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a global healthcare company.
- Responsibilities
- Implementation of acceptance test / shipping test of formulations and packaging materials
Implementation of final product testing on the production line
Understand relevant laws and regulations, pharmaceutical requirements, and their requirements. Also ensure GMP Compliance
Validation/Qualification support when introducing test methods and equipment
Contribution to achieving business goals set by the department
Testing of drug products and / or packaging materials is performed in accordance with relevant SOPs , etc.
Perform final product testing in accordance with relevant SOPs , etc.
Review and approve study results ( primary approval ) in accordance with relevant SOP/cGMP .
Participate in and support test method validation when introducing new test methods / revising test methods
Support QC- related projects for launching new formulations
Participation in and support for Qualification when analytical equipment troubles
Ensuring GMP compliance in QC related processes
Achieve the business goals set by the department and contribute to the achievement of those goals
Responsibility for education / training such as in-house e- learning system
Continuously improve and acquire skills to improve the efficiency of daily work
Emely Motol
Pharma -
NEWJob number: Job-00255754 Posted: 2023-09-27
【東京】製造所等の品質及びGMPコンプライアンスの向上・改善活動業務
自己点検あるいは監査の経験ある方歓迎6.36 - 12.6 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a cutting-edge biotechnology company.
- Responsibilities
- ■業務内容：
製造所などの品質及びGMPコンプライアンスの向上プログラムをリードしていただきます。中長期的な視点から、製造所のGMP、品質及びコンプライアンス向上のための施策の立案及び実行
自己点検を通じて、社内の複数の部署に跨るGxP業務の改善活動
■業務の魅力：グローバルスペシャリティファーマへの飛躍を掲げ、グローバルベースの品質システム構築を進めており、その変革期を体験することが出来ます。
製造所のGMP、品質及びコンプライアンスの向上プログラムを通じて、製品に関する知見、製造委託先管理の経験を深めることが出来ます。"
Patrick Chang
Pharma -
NEWJob number: Job-00255693 Posted: 2023-09-26
品質保証（GQP対応）
グローバル対応含め多くの経験が積めます／平均年齢42.1歳／平均勤続年数14.7年5 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client mainly engages in the research and development, manufacturing, sales, and import/export of pharmaceutical products.
- Responsibilities
- ■業務詳細：
医薬品および医療機器の品質保証業務製造所管理（品質取決め、品質監査）
変更／逸脱／CAPA（是正措置・予防措置）の管理
品質情報（苦情を含む）の管理
品質不良／回収対応
文書管理（品質標準書、手順書の制改訂等）
■業務の特徴・魅力： 医薬品および医療機器の品質に関する様々な幅広い経験を積むことができます。特に、近年導入品や海外メーカーとのやり取りが多数発生しているため、グローバル対応も含む多くの経験が積めます。
Patrick Chang
Pharma -
Job number: Job-00247462 Posted: 2023-09-21
【品川】品質マネジメント
コンプライアンスマネジメントの知識および実務経験がある方必見です。6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is Global Leading Pharmaceutical Company.
- Responsibilities
- 市販後の有害事象情報収集や分析、評価、報告等のPV（ファーマコビジランス）業務を行う安全性管理実施部門に対して、品質マネジメント担当者として、リスク軽減策のアドバイス、コンプライアンスマネジメント（CAPAマメジメントを含む）を行う。
GVP/GPSP業務に関連する当局査察、外部提携会社による監査への対応業務（査察準備、ファシリテーション、トレーニング等）
マネジメントレビューの実施（品質レポートの作成、指標設定を含む）
GVP、GPSP関連法規制の適用に関するアドバイスおよび法規制変更時の社内対応推進（手順書改訂サポート、トレーニングを含む）
Patrick Chang
Pharma -
Job number: Job-00249524 Posted: 2023-09-21
QC Team Leader
line management7 - 11 million yen Other Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a global healthcare company.
- Responsibilities
- As our Quality Control team Leader, you are to manage and supervise the QC (Quality Control) projects/QC activities systematically and properly according to the product specifications and Quality Control Standard Code. to create or update the relevant contents.
Enhance the relationship between the QC relevant stakeholders to assure the internal compliance with the support of QC Senior Manager when needed.
Lead QC team members to perform the requested tests and accordingly contribute on the stable supply of the high-quality products and also comprehensively to enhance Collaborative awareness within the team.
Ensure high performance and effectiveness of QC team operations, timely and sufficient training and professional development employees in QC team with advice from QC Senior Manager.
Manage and supervise the activities related to QC tasks such as reception control tests, release tests, etc would be performed properly.
Improve the process or procedures by implementing MRA, considering of QC test outsourcing and introducing certified supplier to seek for higher efficiency. the stable supply of high-quality products by making a QC equipment/machine/system management plan.
Ensure strict compliance of QC process and operations in accordance with SOPs and other internal and external requirements. according to the QC plan.
Ensure the timely launch of new products by enhancing the collaborative awareness of the team members.
Support the chemists and the technicians whenever new system or equipment is implemented to perform proper validation tests.
Gather and understand the latest global SOP and Japanese regulations to instruct and review the new/updated contents in order to ensure compliance of the regulatory requirements and their internal Ensure the timely launch of new products by enhancing the collaborative awareness of the team members.
Support chemists and technicians to perform the requested test for new product launch or handling customer complaints.
Use Systematic Problem Solving for resolving team problems (Deviation, Laboratory error) not to affect the product release.
Evaluate and report to own manager the resources needed to fulfill the QC processes to assure the stable supply of high-quality products.
Enhance Kaizen/cLean Provide teaching and coaching to motivate and develop the team members to raise the team level.
Also, follow-up on employee goals and targets and on the team members' individual development plans discussing with QC Senior Manager.
Emely Motol
Pharma -
Job number: Job-00255412 Posted: 2023-09-20
リーダー候補/医薬品添加剤、食品添加物の品質保証
分野を問わず製造業での品質保証業務経験が活かせます。7.2 - 11 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a general chemical manufacturer.
- Responsibilities
- 製造拠点のQMS運用支援（顧客監査、審査対応等）
顧客からの品質保証関連調査依頼対応
製品の品質規格書作成
国内外（特に海外）のレギュレーション調査及びその対応
海外代理店管理…代理店の法順守状況の確認・教育（WEB会議/現地訪問確認)
Patrick Chang
Pharma -
Job number: Job-00240459 Posted: 2023-09-09
Manager, Quality Assurance
generic company10 - 13 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- The company is a foreign-affiliated pharmaceutical company.
- Responsibilities
- Qualify, manage, support and supervise assigned CMO and API suppliers aligned with the Quality Management Systems and provide reports as required
Support team management for GQP Head on day-to-day basis
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
Plan, organize and lead periodic internal reviews with all stakeholders (e.g. Audit, Supply Chain, Quality Compliance)
Implement and maintain Regional CMO data
Perform other duties as assigned such as described below:
Ensure the Quality Assurance Agreements which are created and maintained according to their requirements, are regularly reviewed and followed
Execute, implement and maintain an ongoing Quality Risk Management program that assesses the CMO sites as applicable
Conduct review and approve batch release documentation
Manage (initiate and investigate) all significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
Implement CMO and product risk analysis as well oversight and approval of validation and qualification processes.
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 Global QA Biologics and CM projects as required
Support business development for new CMO projects including due diligence audits and CMO qualification
Develop, implement and maintain Sun
Emely Motol
Pharma -
Job number: Job-00231579 Posted: 2023-09-06
QA Manager
People management9 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- 同社は、医薬品事業を展開しています。
- Responsibilities
- 製造販売する製品の品質保証業務に関与し、主担当者として担当した業務については、他の信頼性保証部員の指導的な立場で業務を推進する責任を有する。
薬機法コンプライアンスと製品の品質安定と改善を重視し、判断や決定を行うとともに、その内容は品質保証部部長と共有しながら業務を推進する。
責任者として担当する業務（変更管理、製品苦情、品質の取り決め、逸脱管理等）を適切に実施し、製品品質を維持するとともに、製品の安定供給に寄与する。
製造所の品質監査や年次照査結果の評価等を通じて、製造所のGMPレベルの向上と技術力の改善に貢献する。
新製品導入や新規製造委託等のプロジェクトに参加し、決められた期限を厳守しながら、製品品質と安定供給の観点からプロジェクトの実施に寄与する。
グローバル本社の品質部門と連携し、様々な情報交換を通じて課題解決の推進を図る。
Emely Motol
Pharma -
Job number: Job-00254386 Posted: 2023-09-06
バイオ医薬品品質保証・統括業務（査察対応・サプライヤー管理・プロセスエクセレンス・GMP統括/薬制）
品質管理に関わる業務経験者必見です!5.18 - 12.6 million yen Other Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a cutting-edge biotechnology company.
- Responsibilities
- GMPに沿った品質保証業務
当局査察対応
自己点検
サプライヤー管理
パートナー会社とのコミュニケーション
CAPA管理
品質リスクマネジメント
工場内の部署横断的な業務推進および関係部署の課題解決支援
Quality culture醸成活動
KPI/リスクレジスター管理
承認書維持管理、薬事支援業務
薬制業務
その他
Patrick Chang
Pharma -
Job number: Job-00250487 Posted: 2023-08-24
バイオ医薬品の品質管理統括業務
語学力を活かしてグローバルに活躍7.2 - 13 million yen Other Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a cutting-edge biotechnology company.
- Responsibilities
- 医薬品、治験薬等のGMP管理試験室での以下の試験を主とする品質管理業務
製品ラボメンバーの統括管理（マネジメント）
医薬品の品質管理に関するグローバルＧＭＰ体制の整備
規制当局/協力会社に対する査察/監査対応
バイオ医薬品の規格試験及び安定性試験の統括
分析委託先への技術移管・技術支援
Patrick Chang
Pharma -
Job number: Job-00251027 Posted: 2023-08-07
QC Laboratory Staff
Shiga Plant (good location)5 - 8 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
- Responsibilities
- 品質管理部門の試験責任者として、原材料及び製品の受入試験、出荷試験及び検討試験等の品質 試験、クオリフィケーション、バリデーション、分析機器の管理等の業務を計画的に実施し，高品 質な製品の安定供給に寄与する。
薬機法、最新のGMPや日本薬局方などの規制要件および社内の品質基準を理解し、それらを高い レベルで満足する品質管理
品質保証の仕組みを構築、維持する。
逸脱/変更管理対応。
製品標準書、SOP、試験計画書/報告書等の文書作成。
Operational Excellence活動を通じてリーンなプロセスを構築する。
後進の教育やコーチングを行い知識・スキル・技術力・マインドを向上させ，最適なチーム構築 に貢献する。
採用者の経験とスキルに応じて以下の業務のいずれかを選択する:
製品・原材料の無菌試験，微生物限度試験及び製造環境や製造用水の微生物学的なモニタリ ング
生物学的製剤の理化学試験，生化学試験
固形製剤の理化学試験
Emely Motol
Pharma -
Job number: Job-00239725 Posted: 2023-08-03
Associate/Manager/Sr Manager-PQA-QA
Kobe office10 - 15 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- Ensuring appropriate quality control at domestic and overseas manufacturing sites for pharmaceuticals, medical devices, and combination products
Establish and maintain internal standards in accordance with applicable regulatory requirements and their Corporate Standards
Conclusion and maintenance of agreements with manufacturers, alliance partners, etc.
Implementation of GQP/QMS quality assurance operations (deviations, complaints, changes, shipping decisions, etc.) based on cooperation with manufacturers, distributors, internal departments and their Corporate
Guidance and promotion of continuous quality improvement activities including manufacturers for the purpose of achieving customer satisfaction
Responding to GMP/QMS inspections to launch new products and maintain approval of approved products
Responding to customer inquiries in collaboration with the complaint management team
Emely Motol
Pharma -
Job number: Job-00252380 Posted: 2023-07-27
【東京／本社】QARAグローバルQA部門 企画スタッフ
プロジェクトマネジメント経験者必見です!6 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is Global Leading Pharmaceutical Company.
- Responsibilities
- 複数GXP-QA（GMP,GCP,GLP,CSPV,MA,GQP等）や他部門・ユニット（グローバル）を跨る新規検討案件や改善案件の施策立案及びプロジェクトリード
グローバルQA組織における中計・年度業績目標の立案、パフォーマンスの把握と推進
DX、デジタルテクノロジーの活用推進に向けた施策立案、プロジェクトリード
Patrick Chang
Pharma -
Job number: Job-00247289 Posted: 2023-07-25
QA Professional (Koriyama Factory)
Replacement position5 - 8 million yen Other Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a global healthcare company.
- Responsibilities
- QAルーティン業務70%（製品の出荷判定、変更要求の承認、逸脱承認、クレーム対応、欠陥の処理、グローバルとの連絡）
プロジェクト10%（新製品や新システムの導入準備など）
QA Oversight 20%（イニシアチブ取り、プロセスを実装および管理、製造現場に入るチェック）
Emely Motol
Pharma -
Job number: Job-00242587 Posted: 2023-07-19
Supplier Quality Management, Quality Assurance
世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか?5 - 13 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a research-based global pharmaceutical company.
- Responsibilities
- ■役割概要: リードスペシャリストとして、関連する部門をリードし、管理する
グループ全体のコラボレーションを推進し、積極的な問題解決とプロセスの継続的な改善を図る
チームワークを促進するための人材育成とオープンカルチャーを推進する
■職務内容:MH/ベンダーの品質保証契約を管理し、タイムリーに準備する
新規ベンダーの認定プロセスを管理する
認定されたベンダーを管理し、常に最新の状況を把握する
関係者と協力し、品質活動の効率化、平準化、標準化を推進する
品質に関する必要な業務をリードし、期限内に完了させる
パフォーマンス・ダイアログを通じてKPI進捗を管理する
優先順位、行動計画、期待される役割、スケジュールなどを示し、チームメンバーのやる気とコミットメントを引き出す
複数のスキルを持つ人材を育成し、次の部門のリーダーとしての準備をさせる
継続的に改善を行う機会（AGILE）を特定し、改善策の実施に関与し、支援またはリードする
Patrick Chang
Pharma -
Job number: Job-00237795 Posted: 2023-07-14
Observational Study Manager
rich pipeline10 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the top medicine and Clinical Research companies worldwide.
- Responsibilities
- 市販後では、開発試験（治験）の次のステップとして、GPSP省令下で行う使用成績調査（PMS）／データベース調査（DBR）／製販後臨床試験（PMCT）により、安全性や有効性を確認していきます。また薬に付加価値をつけていくために、非GPSP省令（倫理指針）下で医療機関を用いるヘルスアウトカム調査(HO Study)なども実施していきます。
Observational Study Managerは、上記のような観察研究の計画・実行をStudy Managerとしてリードしていく役割になります。
[製販後調査（PMS, DBR）におけるStudy Manager業務]薬機法、GPSP,GVPや公正競争規約等のコンプライアンスを遵守し、Study Managerとして製造販売後調査を適切に計画、実施、管理する。StudyのProject managementとしてtimeline、budget、risk/issue、governance/committeeの管理を行なう。
Studyのdeliverableである報告書作成（安全性定期報告書、再審査申請資料、publication etc）にもcross-functionalに協働し、顧客に安全性情報および適正使用情報の提供に貢献する。最終的なPMDA適合性調査対応を行なう。
[ヘルスアウトカム調査におけるStudy Manager業務]臨床研究に関する倫理指針、社内SOPや公正競争規約等のコンプライアンスを遵守し、Health Outcome Studyを他部署と連携し、Study managerとして適切に計画、実施、管理する。
Local Medical Planに紐づくHO study全体のProject managerとして、timeline、budget、risk/issue、governance/committee（Change plan含む）の管理を行う。
Emely Motol
Pharma -
Job number: Job-00250084 Posted: 2023-07-06
Head of Solids Group 1
lead new projects10 - 12 million yen Kansai Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
- Responsibilities
- To appropriately lead the projects such as new launch, manufacturing site change, excipient change, etc. by collaborating with related parties, clarifying necessary activities, establishing timeline, monitoring their progress, project budget planning, etc.
To appropriately establish manufacturing process in commercial scale by exchanging information with related parties, properly executing industrialization (e.g. process development, scale up, validation)in complying with related regulations (GMP, GSOPs, local regulation etc.).
To appropriately improve manufacturing efficiency by acquiring the most reliable technology/information, rationalizing the manufacturing procedure, developing manufacturing technology and executing process evaluation through trials in lab/pilot/production scale.
To appropriately improve product quality through evaluation of various problems in formulation process, annual product quality review, retrospective validation, investigation of user s complaints from pharmaceutical technology point of view
To maintain the compliance with GMP regulations and their policy & directives (ex. TAC inspection) by implementing necessary procedures such as preparation of necessary GMP related SOPs, proper validation, cooperation for authority s inspection for new products, etc.
Based on PSJ policy, to provide subordinates with training opportunities and direct instructions to cultivate the ability of each person and to be flexible to variety of works. In addition, to strength HSE & OE activities and LIFE culture.
In line with their policy, to implement the approved budget and personnel administration by making/ executing an effective budget, grasping/ managing the working conditions and current status of subordinates
Emely Motol
Pharma -
Job number: Job-00212962 Posted: 2023-07-03
[Tokyo/Shizuoka/Ibaraki] QA for Drug Development and New Product Launch
Rich Pipeline and Global Culture7 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a global pharmaceutical company with its own distribution channels around the world.
- Responsibilities
- Contribute to development projects by ensuring the quality of investigational drugs used in clinical trials conducted globally and complying with regulations such as GMP.
Promotion of quality assurance operations such as management of investigational drugs, investigational drug substances and new product manufacturing contractors, change management in the development phase, implementation of quality audits, shipment of investigational drugs by appropriate product quality management, etc.
Building and collaborating with joint development partners
Improvement of global quality assurance system for developed products, continuous improvement, promotion of new regulation compliance
Promote regulatory inspection response and inspection preparation in cooperation with related departments such as laboratories, manufacturing contractors, and supply chains so that early application and launch of new products can meet and respond to regulatory requirements globally.
Participate in the global working team within Quality Assurance and Quality Technology to solve quality assurance issues and improve and improve the quality assurance system.
Initial development phase Quality assurance work at product manufacturing plants such as regenerative medicine
Martin Tsvetkov
Pharma -
Job number: Job-00210946 Posted: 2023-06-26
Associate Director, Quality Assurance
Quality Assurance6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is developing and providing various medicines for an array of health concerns.
- Responsibilities
- The Commercial Quality Lead - Japan has the overall Quality oversight & responsibility to ensure Quality and Regulatory compliance of all Commercialized Products, Japan LOC , Consumer related Distribution Centers and Warehouses within Japan base business, ensuring all applicable regulations as well as Enterprise Quality Policy Standards and procedures . The incumbent is also responsible for end-to-end Franchise Quality under Marketing Authorization and Quality Management System (QMS).
This position is also responsible for Quality Assurance Supervisor (QP) who is accountable for quality assurance of Marketing Authorization products and reports to General Marketing Supervisor (SoSeki) in good collaboration with Safety Management Supervisor (AnSeki).
Patrick Chang
Pharma
12