Job Description
Position Purpose
Quality Assurance Associate - Japan - 日常の品質案件(市場への出荷の決定,逸脱処理,品質情報処理,変更管理)をグローバルCSLB社の基準や本邦の規制に沿って適切に遂行する
To operate appropriately routine quality events (market release, deviation, complaint and change) in compliance with internal / global CSLB policies and local regulatory requirements
- 社内の他部門(営業本部,マーケティング本部,メディカル本部,薬事部,製造サイトなど)との連携
To collaborate with internal partners, such as sales department, marketing department, medical affairs, regulatory affairs and manufacturing sites
- 外部の顧客(医療機関,患者,特約店,物流センター,試験機関など)との適切なコミュニケーション
To appropriately communicate with the local external customers and parties, such as hospital, patients, wholesaler, physicians, J-3PL and laboratories
- グローバルCSLB社の基準や本邦の規制要件に沿った簡素で標準化された新しい手順の確立
To establish new simple and clear operational practices in accordance with the global policy and local regulatory requirements
Responsibilities
To conduct SLP (Summary Lot Protocol) preparation and batch release activities. Negotiate with NIID on lot release queries and feedback
日常の品質案件(市場への出荷の決定,逸脱処理,品質情報処理,変更管理)をグローバルCSLB社の基準や本邦の規制に沿って適切に遂行する
To Operate routine QA activities mainly customer supports, such as complaint handling and query respond in compliance with internal / global policies and local regulatory requirements
社内の他部門との連携
To Collaborate with internal partners
- 製造所:変更管理,逸脱及び苦情調査の依頼と回答書の作成
Manufacturing sites: to manage changes, to request investigation for deviations / complaints and create customer communication letter
- 薬事部:変更管理,承認書と製造実態に相違が無いことの点検
Regulatory Affairs: to manage changes, to check whether or not there’s no discrepancy between the registered dossiers and the actual operation
- 営業本部及びマーケティング本部:日常の安定的なコマーシャル業務の支援(とくに苦情処理)
Sales and Marketing: to support stable commercial operations, especially complaint handling
Medical and Regulatory Affairs: to mutually prepare query respond
外部の顧客(医療機関,患者,特約店,物流センター,試験機関など)との適切なコミュニケーション
To Communicate with external customers and parties (hospital, wholesaler, physician, 3PL, external laboratories)
グローバルCSLBの基準や本邦の規制要件に沿った簡素で標準化された新しい手順の確立
To Establish new simple and clear operational practice in accordance with the global policy
特命事項の実行(必要に応じて)
To Oversee projects, if necessary
Position Qualifications and Experience Requirements Bachelor degree or equivalent degree holder
Intermediate or Advanced level in English (reading and writing, conversation)
- 製薬企業での3年以上の業務経験もしくはGxP(GMPやGQPの経験が好ましい)の経験
More than 3 years Experiences in working at Pharmaceutical industries and / or GxP (preferable; GMP and GQP) fields.
Background and knowledge in Plasma manufacturing and Quality Control testing
Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
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