外資原薬メーカーにてQAマネージャー【薬剤師】

外資原薬企業にてQAマネージャーとして担っていただきます。

仕事内容

・Contribution to Quality Assurance system/organization
・Contributes to management of Quality Assurance of the Japan zone in relation with Sales
QARA Corporate
・Coordinates Quality Assurance activities with regard to GMP/GDP : Procedure Management,Deviation & CAPA management, Complaint Management, Product Quality Review, Third PartyAudit, Analytical and third party logistics subcontractor management, …
・Ensure ITS quality system administration though the QMS ITS application : Phenix E&C and QTP,
GEODE.
・Manage customer complaints and quality information provided by API sites and also manage event at external laboratories.
・Management of GMP/GDP at Japan DC center and Head office:
・Contribute to GMP activities of , such as batch release, deviation & change controls, maintenance of SOPs, training, self-inspection, PQR (Product Quality
Review) and QSR (Quality System Review).
・Takes role assigned position of GMP organization, related to third party distribution center activities, such as Security Pharmacist or its delegate and other responsibilities, such as Batch Release, Deviation management, Change Control
management, Document Archiving etc.
・Ensure compliance of GMP/GDP under requirements of Japanese Pharma Law, Global Quality Guidelines and related guidelines, i.e. PIC/S.
・Inspection readiness for Japanese authority, Tokyo Metropolitan office, and for customer audits.
・Manage QAA contracts (global and local) between Marketing Authorization Holders Japan.
・Perform audit service providers and external API suppliers to ensue management of the services and supplies.
・Contributes to the Change Control process at API sites for quality assessment.
・Role of key interlocutor of the Japan Health Authority, i.e. Japanese Pharmacopeia, ICH M7.
・Manage customer quality related requests, i.e. ICH Q3C, Q3D, Nitrosamines, BSE/TSE compliance.
Contribution to Regulatory system/organization of Sales
・Contributes to management of FMA/JMF registered dossiers and GMP compliance review with communication between API sites, PMDA and regulatory representatives of the customers.
・Registration of JMF, if necessary, support for submission/ registration to Asian territory.
・Submit MCN/PCA, if applicable initiate PMDA consultation
・Answer for deficiency letters at PCA/initial and periodical GMP inspection
・Periodical FMA update
・Management customer request
・Annual consistency check
LoA contract
・Contributes to the Change Control process at API sites for regulatory assessment.
・Contribution to the key account customer and CDMO activity in
・Contribute and support quality and regulatory action by Key Account Customer in Japan such as registrations in EU/Asia /US.
・Contribute and support quality action required by CDMO activities (Contract Development Manufacturing Organisations).
Contribution to the development of a Sales QA/RA network
・Takes part of the quality and regulatory network (EU, US, Japan, China, Russia) sharing innovation
initiatives, continuous improvement, and best practices exchange.
・Takes part of training sessions for Japan members and oversea API sites on the points of specific quality requirements and Japanese Pharmaceutical and Medical Device Act. And relevant
regulatory requirements.
Assures API Quality and Regulatory Intelligence
・Follows evolution of the Regulation in Japan and inform QARA Corporate.
・If applicable, act as company representative at social position in Japan, such as member of Pharmaceutica

応募条件

【必須事項】

Education: University degree in Pharmacy：
・ Experience & knowledge: Minimum of 5 years in the pharmaceutical
industry with strong background in International Quality Assurance,
Regulatory, Chemistry part of dossiers.
・Core competencies: Background in active ingredient / drug product
production, Analytics, Regulatory Affairs and registration regulations.
・Pharmacist (Mandatory)

スキル：
・English Speaking / intermediate or Fluent
・Quality and regulatory background
・GMP expertise
・Experience on new JMF registration and its maintenance
・Skill of management experience with demonstrated leadership,
communication and problem solving/conflict resolution skills, good
conviction strengths.
・Self-driven, Results-oriented, multi-tasker with excellent personal
・Ability to work cross-functionally, strong team player
・Excellent problem-solving skills, analytical thinking and strategic
capabilities
・Effective communication and interpersonal skills

【歓迎経験】

【免許・資格】

薬剤師資格

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
コアタイムあり
　10:00 ～ 15:00

勤務開始日

応相談

休日休暇

土日祝
年間有給休暇：　
法定休暇：年次有給休暇
特別休暇：年末年始休暇
その他休暇：会社指定休日

年収・給与

年収　　800万円～1400万円　経験により応相談

諸手当

通勤手当

昇給

有

賞与

採用人数

1名　

待遇・福利厚生

通勤手当：有
住宅手当：有
確定拠出年金制度、通勤交通費支給（月5万円上限）リロクラブ、団体保険

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
定年：60歳

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接