**ベーリンガーインゲルハイム製薬株式会社** **勤務地：大崎オフィス（国内出張あり）** **＊日本語の応募書類に加え、できれば英語** **CVもご送付をいただけますと幸いです。** 1. CMOにて発生する各種変更(原薬・副原料・機器等)に対して、CMOからのQualification計画を製剤技術の観点からReviewし、実行する。 （工業化検討・PQ/PV計画書/報告書Review, 必要に応じて現場立会い）　 同様にCMOと協議し、Process堅牢化・改善を進める。 2. 新製品の中で、ドイツからの完成品輸入品、国内CMO包装品について、立上げ準備を行う。 　 技術的な立場から日本国内での新製品立ち上げProjectに参画し、ドイツ・国内CMOと協力しながら準備を進める。 3. CMOにて発生する各種変更に伴う、承認書への記載内容変更案のReview 新製品の薬事申請書類のReview **Basic purpose of the job*** •Prepare for the initial production for the launch of new products (FG import or Japanese CMO packaging) providing technical support. •Implement smooth technology transfer(mainly packaging) between launch site to Japanese CMO. •Product qualification (including trials) related to changes in API, material and equipment at Japanese CMO. (Bulk manufacturing and packaging) •Realise the robustness of the manufacturing process for the products, achieve high quality and competitive cost at CMO. •Authoring and review CMC documents for change application in Japan for CMO related changes and initial launch(FG Import and CMO). •Manage timeline and cost related to qualification for intended changes at CMO. •Support to the other groups to deliver the results as planned within timeline and cost. •Contribute to BPE, Kaizen and other strategic initiatives in HP Supply Japan. Accountabilities* 1. Secure the initial production of new products developed internationally with no delays in Japan (FG Import or Japanese CMO packaging) 2. Product qualification (including trials) related to changes in API, material and equipment at Japanese CMO. (Bulk manufacturing and packaging) 3. Realise the robustness of the manufacturing process for the products, achieve high quality and competitive cost at CMO. 4. Authoring and review CMC documents for change application in Japan for CMO related changes and initial launch (FG Import and CMO) 5. Manage timeline and cost related to qualification for intended changes at CMO Degree / Education Bachelor degree of above Major / Focus Background in pharmaceutical science, engineering, production management, material management or the equivalent in experience Required Skills Special Skills ・Extensive knowledge and experience in manufacturing/packaging equipment & processes of pharmaceutical products. ・Well understanding of regulations (GMP, Japanese regulations, etc.) ・Experience in CMC documentation ・Communication skill and strong negotiation skill Language： English：Business Level Japanese：Native or Business Level リクルーター：大薗 All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.