Job Advert Title: Quality Assurance, JAO GDP
Location: Nihonbashi,Tokyo
Division: Quality Assurance
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
Acts as the primary QA responsible for Japan Good Distribution Practice (GDP) QA oversight of Storage and Distribution activities related to upstream supply chain for commercial products. Provides support for daily activities between Astellas stakeholders including T&M, other QA teams and external third-party logistics providers to ensure effective quality systems that meet Good Manufacturing Practice (GMP), GDP, and established Astellas requirements. Supports JP Affiliate QA for QA release activities related to commercial products based on risk.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
•Supports the maintenance and enhancement of the global Astellas GDP QA Quality Management System (QMS) related activities through cross functional team working, specifically self-inspection, KPI monitoring and quality management review processes.
•Ensures timely documentation of GDP related nonconformances in TrackWise digital with root cause identification and actions for prevention as well as appropriate affected batch disposition based on quality and safety perspective.
•Assesses and approves GDP related changes in TrackWise digital.
•Reviews and approves transportation study documents prepared for new product launch and GDP relevant changes.
•Quality oversight of contracted 3PLs and Freight Forwarders to ensure their quality management system is maintained and enhanced through nonconformance/CAPA management, Business Review Meeting, Auditing, Quality Agreement maintenance and periodical GDP Risk Assessment.
•Ensure Astellas products are distributed in a timely manner through Usage Decision in SAP S/4 in collaboration with JP affiliate QA, SCM and distribution centers.
（変更の範囲）
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】
•This position is based in Tokyo, Japan.
•At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
【応募要件 / Qualifications】
＜必須 / Required＞
•Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree
•Track record of demonstrable and relevant minimum 3 years’ experience within QA, specifically GMP/GDP areas.
•Good understanding of establishing and maintaining (GxP) Quality Management Systems.
•Proficiency in local language (Japanese) and business English language (written, verbal, presentation, facilitation)
•Ability to represent the company to external stakeholders.
•Ability to apply industry knowledge and interpretation to anticipate global impact and contribute ideas for strategies and levels of management.
•Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.
•Can develop / execute quality strategies with management guidance.
•Makes decisions for the department in their area of quality expertise with management oversight.
Skills and competencies:
•Good communication and negotiation skills and willing to build collaboration relationships.
•Good problem-solving and solution-oriented skills.
＜歓迎 / Preferred＞
•Experience with Trackwise (Digital), Veeva and SAP systems
•Experience in supporting regulatory interfaces such as GDP inspections and audits.
•Experience in conducting GMP/GDP audits
【応募書類 / Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed
【選考プロセス / Selection details】
書類選考 → 1次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
（変更の範囲）
会社の定める事業場および自宅
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
①基本給：当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給
③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:45～17:45（月～木）、8:45～16:00（金）
8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
Discretionary Work System
【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."