External Manufacturing QA Operations Coordinator - 製薬会社

勤務地 東京都
雇用形態 正社員
給与 ¥6000000.00 - ¥8000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 品質管理 / 品質保証,
お問合せ Yoshiko Kumakura
JOB ID JO-2109-463803

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

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[Position] External Manufacturing QA Operations Coordinator
[Location] 東京都
[Salary] 6〜8 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系製薬会社

  • 「世界で評判のいい製薬会社」ランキング上に選ばれる社会的評価の高い会社です

[Responsibilities]

  • Coordinates deviations from third-party contractors in the context of manufacturing of APIs, bulk, intermediates, final drug products including quality control, medical devices and transportation.
  • Escalate critical deviations and complaints to line management.
  • Supports resolving deviations and implementation of CAPAs assuring timely completion. Must use scientific judgment to ask key questions during root cause investigations.
  • Coordinates and assesses product technical complaints (root cause, impact/risk assessment), ensuring investigation statement timely completion in complaint database.
  • Manages changes from third-party contractors as Local Change Manager in change management database including review and approval of related documents and Bill of Materials.
  • Tracks timely preparation of APQRs. Compiles PQR summary reports. Checks/reviews PQR Data and escalates discrepancies to line management.
  • Prepares and updates SOPs and quality documents in area of responsibility.
  • Key-User for IT systems for changes, deviations, complaints and CAPAs.
  • Provide support in the context of regulatory agency inspections and requests from Health Authorities.
  • Maintain awareness of current GMP trends (e.g. FDA, EMA, PhEur, JP) and pharmaceutical manufacturing processes. Supports continuous improvement within QA.
  • Provide tracking of KPIs and support data review of key quality attributes and its trending e.g. of critical process parameters and critical quality attributes.
  • Provide expertise and support for projects/launches/changes on request by management.

[Requirements]

  • Experience in the management of external manufacturers (Third parties / CMO) preferred.
  • General knowledge and experience in pharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product inspection and labeling; QC testing; Product disposition and release; Deviation management; Change management; Contract manufacturing
  • cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international health agencies).


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Reference:
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance