Asia NPI Quality Assurance Manager@大手日系製薬会社

求人詳細

- Develop and implement a comprehensive NPI QA strategy for Asia: Aligned with cGMPs, ICH Q9, and other relevant regulations, establishing quality management systems, risk assessment procedures, and validation/verification plans for new products.
- Lead NPI launches within Asia: Guide the cross-functional team including QA specialists in other regions to conduct testing activities, including analytical, stability, performance, and safety assessments that is in line with Asia's regulations.
- Oversee all aspects of NPI quality: Manage documentation, track and resolve deviations/non-conformities, conduct audits, and ensure timely CAPA implementation.
- Champion quality culture: Foster a collaborative environment where quality is embedded in all stages of NPI, from product design to launch and beyond.
- Liaise with cross-functional teams: Partner with R&D, Manufacturing, Regulatory Affairs, and other stakeholders to ensure seamless integration of quality throughout the NPI process.
- Stay abreast of evolving regulations and industry trends: Proactively identify and implement new quality standards and best practices.
- Prepare and deliver presentations/reports: Communicate QA findings and insights effectively to leadership and stakeholders.
- Provide support to resolve all relevant local product quality issues timely to ensure continuous provision of quality compliant company's products in responsible countries.
- Perform/ support quality activities and resolve quality issues for companies in responsible countries and/or region to support the continuous supply of company products in these countries in compliance to applicable local regulatory authority and our global/ release requirements. 

こんな方を求めています

経験・スキル

10-14 years’ experience in Pharmaceutical Company in quality function with 5 years in NPI or similar environment.
Demonstrated expertise in cGMPs, ICH Q9, and other relevant regulations.
Strong understanding of analytical methods, stability testing, and quality risk management.
Business English and native level of Japanese skill

学歴

大学卒業以上

募集要項

職種

安全性管理、品質保証、品質管理

給与

年収 900 〜 1,200万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り
3か月

就業時間

08:30～17:15

休日休暇

日曜日,土曜日,祝日
年間123日　（土日、祝日　※当社就業カレンダーに基づく）

保険

健康保険,厚生年金保険,雇用保険,労災保険

待遇・福利厚生

＜教育制度・資格補助補足＞
入社後1週間程度、座学にて商品知識などご習得いただいたのち、現場配属となります。※研修は現在WEBで実施
現場配属後はOJTにて、担当MRや上長がしっかりサポートいたします。

＜その他補足＞
社会保険完備、法定外労災補償制度

業種

医療機器・医療品関連

※詳細はお仕事のご紹介時にお伝えします