GMDP Auditor, Quality Audit Excellence

General Information

• Job Advert Title: GMDP Auditor, Quality Audit Excellence

Location: Nihonbashi,Tokyo

Division: Quality Assurance

Employment Class: Permanent

Description

【募集の背景 / Purpose & Scope】 Conducts cGMP, cGDP or device audits of suppliers and internal entities and systems in support of the supplier evaluation and risk assessment program.

【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） 1.Leads cGMDP audits of suppliers in support of the supplier evaluation and risk assessment program to identify / evaluates all risks. Develops and distributes formal reports in a collaborative manner. Ensures related databases are updated in a timely manner and generates status reports as required. 2.Leads internal cGMDP and medical device audits. Identifies and evaluates relevant potential internal quality and compliance issues, signals and trends. Prepares and distributes formal reports in a timely manner. Updates related databases in a timely manner and generates status reports as required. 3.Participates as the QA representative on Astellas projects and working teams as assigned. 4.Supports continuous improvement, innovation, compliance and monitoring initiatives as Astellas continually invests in new products, processes and systems. 5.Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., SOPs, STLs, Forms, etc.) as necessary.
（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】 •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. •The position requires significant travel (up to 50%) across the region, with the possibility of occasional long-distance travel.

【応募要件 / Qualifications】 ＜必須 / Required＞ 1.Higher level education in natural science, pharmaceutical / medical subjects, or engineering (minimum bachelor’s degree) or equivalent professional experience. 2.Minimum of 5 years of relevant industry experience including a minimum 2 years of Quality Assurance auditing. 3.Knowledge and understanding of the concepts of Quality Management Systems, the key regulations and guidelines, and the technology used in the manufacture, testing and distribution of medicinal products and medical devices. 4.Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Astellas group and with external stakeholders. 5.Proficiency in English. 6.Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies. 7.Ability to work independently, particularly to plan and execute audits in an effective and compliant manner with limited management oversight.
＜歓迎 / Preferred＞ 1.cGMP and cGDP auditing experience and Sterile Product Manufacturing experience desired. 2.Knowledge of the technology required for the manufacturing and testing of Biological Medicinal Products and Advanced Therapy Medicinal Products (ATMPs) and experience in auditing the same. 3.Prior leadership experience with or without formal authority.

【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.

【勤務時間 / Working Hours】 8:45～17:45（月～木）、8:45～16:00（金）、専門業務型 裁量労働制裁量労働制の場合、所定労働時間を働いたものとみなす 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."