Quality Assurance Senior Manager @ 外資系バイオ医薬品企業

求人詳細

Responsible for the Deputy of Quality Assurance Officer (品質保証責任者代行)Manages the operations of several areas of Quality Management System (QMS) within commercial QA including responsibility for work methods, operations excellence, managing costs.Project involvementServes as a project lead within the function.Lead or serve as a key team member on cross-functional projects, which can have high visibility to senior management within the organization.Key Differentiating ContributionsResponsible for maintaining and enhancement of Quality Management System (QMS) with regulatory requirements and Company global standards.Responsible for providing guidance on interpretation and application in accordance with relevant GQP&GMP&GDP regulations.Uses advanced statistical techniques for data analysis. Uses complex research techniques and methodologies such as six sigma and kaizen to improve process/product qualityIndependently initiates and develops new methods to facilitate management’s ability to make strategic decisions.Develops a strong relationship with stakeholders including Trade&Operation (Supply Chain& Wholesaler), CMC-RA, Corporate Quality, Customer Service, Regulatory, PV and Manufacturing to ensure that product distribution processes are aligned to the regulatory requirements and the needs of the company and its customers, ensuring best practice, compliance and alignment with business needs.Support any activities of Quality Head for Quality Management Review.Support any activities of Quality Assurance Officer with contributing to improvement and execution of All GQP/GDP activities including deviation, change management, Quality information, GQP/GDP training, Batch Record Review, CMO management, self-inspection and recall, as a deputy of Quality Assurance OfficerWorks on problems that are complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Determines corrective action on investigative findings and with consideration of the long-term impact of decisions.

こんな方を求めています

経験・スキル

10+ years of QA relevant experience in the pharmaceutical industry and a Master of Science.
5+ years of QA relevant experience with Quality Management System
Experience with Electronic Document Management Systems or other GxP applications.
Experience in Project Management for Launch, site transfer and analytical transfer.
Experience in GMP compliance inspections, FMA and Conformity check.
Experience in analytical, process chemistry and/or formulation development.
Experience in Biologic and Cell Therapy is preferre

学歴

大学卒業以上

募集要項

職種

品質保証/品質管理

給与

年収 800 〜 1,300万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業, フレックスタイム制, 月平均残業時間20時間以内, 年間休日120日以上, 完全週休2日制, 土日祝休み, 語学力を活かす

業種

医療機器・医療品関連

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