治験薬GMP品質保証部門責任者
募集要項
・治験薬GMP関係の品質システムの責任者業務
※逸脱、変更管理、バリデーション、教育訓練等
・他の治験薬GMP組織又は商用製造工場との技術移転等の推進
・治験薬GMP組織内外でトラブル又は逸脱が発生した場合は、各分野の見解を加味し、根本原因、再発防止策の妥当性を品質保証部門として判断する。
・治験薬GMP関連の業務変更を行う際は、リスクアセスメントに基づき検証方法、変更リスクが特定されているか品質保証部門として判断する。
必要な経験・スキル
・医薬品又は治験薬の製造部門、試験部門、品質保証部門いずれかの実務経験2年以上
又は関連業務の3年以上に相当する実務経験
・国内外の医薬品規制に関する知識
・医薬品開発において製剤設計又は分析法開発経験
又は商用医薬品、治験薬医薬品に関する技術移転業務
・データ分析・解析力
・行政による査察対応経験
資格・身分
資格:-
身分:-
行動特性: 高いコミュニケーション能力と探求心、課題解決にむけた推進力
資格:-
身分:-
行動特性: ワークライフのバランスを取れる人材
給与
経験・能力を考慮し、当社規定により算出します
昇給・賞与
昇給:年1回 賞与:年2回(7月、12月)
福利厚生
各種社会保険、社宅制度、財産形成支援制度、自己啓発支援 等
休暇
年次有給休暇、リフレッシュ休暇、育児休業制度、介護休業制度、ボランティア休暇 等
諸手当
住宅手当、通勤手当、出張・外勤手当、時間外労働手当等
休日
毎週土曜日・日曜日、祝日、会社設定休日(GW・夏季・年末年始)等
勤務地
神奈川(平塚) ※第一三共グループは2020年4月より敷地内全面禁煙です。また標準就業時間帯は、事業場内外を問わず禁煙となります。
募集人数
若干名
備考
入社時期:応相談
※エントリー時に学歴・職務経歴書をアップロードする必要がありますので、あらかじめご用意ください。
○学歴・職務経歴書について
・書式は自由です。
・高校からの学歴・職務経歴を記載ください。
・右上に顔写真の貼付をお願いいたします。
・推奨ファイル形式はPDFです。
- Word,Excel,PowerPointもご利用いただけますが
使用するPC環境によりレイアウトが変わる可能性がありますので、
PDFファイルのアップロードをお勧めいたします。
上記4つ以外のファイル形式はアップロードできませんのでご注意ください。
・アップロードできるファイルサイズは最大2MBまでとなります。
-
td 治験薬gmp品質保証部門責任者
15時間前
Hiratsuka, Kanagawa Daiichi Sankyo Japan ¥9,000,000 - ¥12,000,000 per year治験薬GMP品質保証部門責任者 · ・治験薬GMP関係の品質システムの責任者業務、他の治験薬GMP組織又は商用製造工場との技術移転等の推進 · ...
-
td 治験薬gmp品質保証部門スタッフ
3週間前
Hiratsuka, Kanagawa Daiichi Sankyo Japan ¥3,600,000 - ¥4,200,000 per year治験薬GMP関係の品質システムの主担当者業務(責任者をフォローする役割)※逸脱、変更管理、バリデーション、教育訓練等・治験薬製造に関する記録書類の照査を実施・治験薬製造に関するベンダー管理必要な経験・スキル · 医薬品又は治験薬の製造部門、試験部門、品質保証部門いずれかの実務経歴2年以上又は関連業務の3年以上に相当する実務経歴 · ...
-
Fujisawa Takeda Full time¥5,000,000 - ¥10,000,000 per yearPrincipal Scientist or Associate Scientist, Analytical Controls Japan, Analytical Controls · Contribute proactively to pipeline development and strategic discussion as a cross functional team member to plan/coordinate and evaluate impact of decisions across Pharm Sci functions an ...
-
品質マネージャー - 横浜
2日前
神奈川県 横浜市, Telix Pharmaceuticals (APAC) ¥2,000,000 - ¥2,800,000 per yearThe Quality Manager will support the international roll-out of our approved prostate cancer imaging agent and help advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. · ...
-
品質マネージャー - 横浜
3日前
Yokohama, Kanagawa Telix Pharmaceuticals Limited ¥9,000,000 - ¥12,000,000 per yearTelix Pharmaceuticals seeks Quality Manager to oversee manufacturing quality control management at its Japanese facilities. This role ensures compliance with Japanese regulatory requirements (PMDA Ministry of Health Labour Welfare JNMT) The main responsibilities include: GMP(適正製造 ...
-
Shinagawa Boehringer Ingelheim ¥6,000,000 - ¥12,000,000 per yearThe role of an Analyst in the Market Access Strategy Group is to contribute to global strategy for maximizing product value by developing and executing asset strategies. · We are seeking a non-line manager/staff who can provide input on value proposition to Japanese Early Asset t ...
-
Shinagawa-ku, Tokyo Boehringer Ingelheim ¥1,500,000 - ¥3,000,000 per yearWe are seeking a Non-Line Manager/Staff to join our Market Access Strategy Group. The successful candidate will contribute to the development of global market access strategies for our assets. · The ideal candidate will have a university degree and/or graduate degree, with strong ...
-
PAL assessor
3週間前
Shibuya TÜV SÜD ¥5,000,000 - ¥9,000,000At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We b ...
-
Sunto-Gun, Shizuoka, Japan Danaher Corporation Full time¥4,000,000 - ¥6,000,000 per yearJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. · Mainte ...
-
Sunto, Shizuoka, Japan Johnson & Johnson Innovative Medicine Full time¥300,000 - ¥600,000 per yearExecute operations of inspection/production lines complying with the proper procedures on a timely manner and produce good quality products continuously · ...
-
Sagamihara Johnson & Johnson MedTech ¥10,000 - ¥15,000 per yearA Field Service Manager position at Johnson & Johnson in Tokyo, Japan. · 3 years of experience in medical device manufacturing or maintenance. · ...
-
Yokohama GE HealthCare ¥5,000,000 - ¥8,000,000 per yearField engineers are responsible for performing various tasks such as installation maintenance repair conservation billing etc at designated areas while maintaining customer satisfaction levels business growth profits responsibility technical competence improvement including clini ...
-
Field Engineer(多摩)
2ヶ月前
Hino GE HealthCare Full time¥3,000,000 - ¥6,000,000 per yearField Engineer is responsible for maintaining and repairing medical equipment, providing customer support, and ensuring quality and safety standards. They must have strong communication skills, be able to troubleshoot and resolve technical issues, and have a basic understanding o ...
-
Hino, Tokyo GE HealthCare ¥180,000 - ¥300,000 per year+Job summary · A Field Engineer will be responsible for conducting fieldwork in their assigned area, including installation maintenance inspection repair conservation collection business growth and profitability.ResponsibilitiesMaintain equipment by performing regular checkups re ...
-
Hino GE HealthCare ¥2,000,000 - ¥2,800,000 per yearField Engineer is responsible for performing various field work in their designated area, including installation, inspection, repair and maintenance of equipment. They must also ensure customer satisfaction and maintain relationships with customers. · ...
-
Field Engineer(多摩)
15時間前
Hino GE HealthCare ¥1,960,000 - ¥2,800,000 per yearWe are looking for a Field Engineer to join our team. The Field Engineer will be responsible for maintaining and repairing medical equipment in the field. · ...
-
Yokohama, Kanagawa PerkinElmer ¥4,500,000 - ¥5,500,000 per yearThe primary role will focus on installs, repairs, maintenance, validation and qualifications of multi-vendor equipment at customer site. · Provide scheduled and unscheduled corrective maintenance for customers including warranty services within a prescribed time frame and establi ...
-
Ota-ku, Tokyo TD SYNNEX Japan ¥2,400,000 - ¥4,800,000 per yearWe are seeking a Senior Rebate Analyst to join our Finance department. · Specifically, this role involves managing rebate contracts and executing correct accounting procedures for vendors. ...
-
Goldsmith – 彫金師
1ヶ月前
Shibuya Tom Wood Full time¥5,000,000 - ¥7,000,000The Goldsmith will be responsible for operating Tom Wood's in-store jewellery lab in the Shibuya Flagship Store, Tokyo, Japan. This is a unique role in the Japanese retail landscape, combining specialist craftsmanship with customer engagement. · Perform engraving, polishing, resi ...
-
Ota-ku, Tokyo TD SYNNEX Japan ¥1,040,000 - ¥2,400,000 per yearManage Technical Support Engineers and Pre-Sales Members as a Team Manager for the Technical Support & SE Department. Provide engineering services to achieve Broadcom Business department-wide goals. · ...
-
Yokohama PerkinElmer ¥1,700,000 - ¥2,400,000 per yearThis role will focus on installs, · repairs, · maintenance, · validation · & qualifications of multi-vendor equipment at customer site. · ...