Tóm tắt công việc
| Nghề | Nghề yêu cầu kỹ thuật (Bán hàng, Thiết kế, Phát triển, Quản lý sản xuất)／Quản lý sản xuất, Quản lý chất lượng, Quản lý thi công, EHS, PMS |
|---|---|
| Ngành | Y tế／ Các ngành y tế khác |
| Hình thái tuyển dụng | Chưa phân loại |
| Chức vụ | Khác |
| Số lượng tuyển dụng | 1 người |
| Ngày muốn vào làm | - |
| Kỹ năng ngôn ngữ cần thiết |
Tiếng Nhật （Thành thạo） Tiếng Anh （Giao tiếp kinh doanh） |
| Ngôn ngữ có thể sử dụng | - |
| Thời gian làm việc | Khác |
| Ngày nghỉ / Phúc lợi y tế | |
| Hỗ trợ xin visa | - |
| Nhân viên người nước ngoài | - |
Chi tiết công việc
Company Overview
Quality Systems & Compliance Specialist - Top Global Mega Pharma
Job Description
【職務内容】
製造販売業者の品質保証業務における以下の業務：
・ 国内外の規制要件や米国本社のポリシー、ガイドラインに基づき、レギュラトリ―サポート業務を行う。
・ 外国製造業者認定の新規申請・維持管理業務を行う。
・ 国内外の製造業者のGMP適合性調査申請業務を行う（指摘事項対応のサポートを含む）。
・ 製造業者、薬事部門と協働し、製造販売承認申請書と製造実態との定期的な照合（定期点検）業務を行う。
・ 上記関連業務の手順書を作成・整備・維持する。
・ 上記の主な担当業務以外に、GQP業務全般のサポートを行うこともある
Job Description:
Quality Assurance activities of the Marketing Authorization Holder as described below:
・ Assures regulatory support activities operate within established policies/procedures, company requirements, and all applicable governmental regulations (GMP, etc.).
・ Supports foreign site accreditation application and maintenance activities to support new product launches and changes.
・ Support GMP compliance inspections of foreign and domestic manufacturers (to include support for remediation of GMP gaps)
・ In collaboration with Manufacturers and Regulatory functions, support the conformance reviews of site practices against the marketing authorizations.
・ Establish and maintain local procedures for above activities.
・ In addition to above activities, also support Quality Assurance activities as defined in the GQP Regulations.
Requirements
【資格要件】
・ 生物学、微生物学、薬学、化学、化学工学、またはそれと同等の学位を持っていることが望ましい。
・ 品質保証、品質管理に関する深い知識と幅広い経験。
・ 日本語／英語による優れたコミュニケーションスキル。
・ 人脈形成スキル、ステークホルダーと適切な関係を構築するスキル。
・ 国内外の薬事規制、公定書等に精通していること。
・ 非ルーチン、多様な文化の中での業務を扱うための対人能力と強力なリーダーシップスキル。
・ ある程度のファイナンスに関する知識。
Qualifications:
・ BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
・ Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities.
・ Must have strong demonstrated communication skills in Japanese and English.
・ Must be conversant with applicable regulations and compendia governing operations.
・ Some level of contractual and financial awareness is required.
・ Strong interpersonal and leadership skills in dealing with a broad variety of cultures on non-routine matters.
・ Must have demonstrated personal networking and relationship skills.
Về cuộc phỏng vấn
Địa chỉ liên lạc
Specialist, Quality Systems & Compliance
RGF HR Agent
500 〜 900 ten thousand JPY
