Senior Manager QA_NPI @外資系製薬企業

求人詳細

•In coordination with the Associate Director, Quality Country GxP Compliance Japan, the Senior Manager will work to embed Quality requirements into NPI projects and ensure the readiness of the products for Japan NDA and commercial supply.
•Act as Quality representative of Market Authorization Holder (MAH) to release the products in Japan market in the term of GQP ordinance and manage the wholesaler from GDP perspective.
•Establish ways of working with external business partners including related overseas CMOs for drug substance, the finished products and so on, to ensure their suppliers staying compliant with Japan regulatory requirements and company policies.
•Act as Quality liaison of Japan between the local business operational groups, global project team for new product introduction, and external business partners.
•Partner with local and global Quality groups to foster a proactive approach to compliance.
•Oversee the integrity of local Quality Control Laboratory (CLO)
•Ensure that company policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and

こんな方を求めています

経験・スキル

•Strong hands-on GMP/GQP, New Product introduction, Quality Assurance / Compliance experience in pharmaceutical industry.
•Exceptional Global communication and interpersonal skills, and ability to work globally in a matrix environment.
•Business English level
•Accountability and commitment for outcomes and project completion
•Thorough knowledge of applicable local and global regulatory requirements required for GxP compliance and new drug application (NDA).
•Thorough knowledge of GMP/GQP; Product release, Change control, Complaint management, and Quality agreements.
•Thorough knowledge of CMC science such as the process validation, QC testing and so on
•Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
•Holistic understanding on a broad range of pharmaceutical activities and Quality Systems.
•Strong stakeholder management skills

学歴

大学卒業以上

募集要項

職種

品質保証、品質管理

給与

年収 700 〜 1,100万円

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

就業時間

08:45～17:30

休日休暇

日曜日,土曜日,祝日

保険

健康保険,厚生年金保険,介護保険,雇用保険,労災保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業, 土日祝休み, 完全週休2日制

業種

医療機器・医療品関連

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