お仕事情報

お仕事情報

Manager Quality (Specialist QA):SS-4031MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-4031MY
募集職種 Manager Quality (Specialist QA)
職務内容 ・Manages and maintains our International & Distribution Quality (IDQ) GMP/GDP aligned with GQP and Pharmaceutical and Medical Devise Affairs Law (PMDAL) - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices (combination products); and small molecules in solid oral dosage form.
・Contributes to our mission, vision and strategy.
・Leads and contributes new product launch readiness including quality deliverables and GMP inspection (paper and on-site).
・Leading IDQ projects, such as Operational Excellence, LCM, and other commercialization activities, etc.
・Implements GxP system based on IDQ and GQP, such as Change control, Deviation, CAPA, Self-inspection, Training, Complaint, Recall, etc. This may also include Quality Management System contribution for ICH Q10 and other international standards.
・Supports drug regulatory Inspections and medical device surveillance with our colleagues.
・Quality oversight of Contract Manufactures, Contract Laboratories and Logistic Service
Providers (LSPs).
・Supports shipment and distribution of Investigational Product and collaboration with our Clinical Manufacturing Site Quality to maintain product quality as needed.
・Supports Audit program management for key Japanese suppliers to us. These suppliers
may include Contract Laboratories, final packaging materials suppliers and LSPs.
・Contributes the GMP Intelligence Program to assess and monitor Japanese regulations,
standards and guidance documents related to GxP, product testing and Japanese
Pharmacopoeia requirements.
・Potentially role for back-up QP (Hinshitsu Hosho Sekininnsya).
応募要件 Basic Qualification:
・Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality
assurance and quality related activities.
・Demonstrated ability to manage relationship development and maintenance and negotiation skills.
・Experience performing GMP audits that perform analytical testing of biologics, LSPs and
packaging suppliers.
・Pharmaceutical/ Biologics product commercialization and lifecycle management experience.
・Knowledge of regulatory authority inspection processes
・Experience in Japan with multiple language capability (English, Japanese)
・Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
・Self leadership and motivation with high personal integrity and application of Amgen Values in daily operations.
・Must have demonstrated interpersonal skills, including temperament, objectivity and
approach that will facilitate effective interactions with a team of seconded staff.
・Ability for travel to international destinations as needed

Preferred Qualification:
・Leadership experience leading teams, projects, programs or directing the allocation of
resources.
・Experience with Japanese pharmaceutical companies.
・Experience working with biologics (monoclonal antibodies and/or proteins) and small
molecule solid oral dosage forms in Japan
・Experience with Investigational Medicinal Products (IMP) and commercial products
・Pharmacist license is desirable, but not mandatory.
勤務地 東京
年収 1000万円~1300万円
最終学歴 大卒
推奨される資格要件 理系
その他

オンライン登録のご案内

ライフケア・ネットワークではオンライン登録フォームをご用意しています。
ご記入頂きますと、自動的に当社履歴書フォーマットで登録となります。
本サイトへ掲載されていない製薬業界の求人・非公開求人も多数ございます。
弊社転職コンサルタントが全面サポートさせていただきますので、是非一度ご登録ください。

オンライン登録(無料)

ページトップ

Copyright © e-製薬 All Rights Reserved.