GCP QA Auditor at Global Leading Pharma (Kansai)

日本 外資系企業 年収 800万円 - 1300万円 外資系企業
  • Be part of a leading global pharma with cutting edge products/therapies
  • Take lead in GCP QA Auditing activities as a co-auditor and lead auditor

企業情報

  • One of the top global pharmaceutical companies in the industry
  • Rich development pipeline specialising in oncology, CNS, cardiovascular, immunology, etc. for unmet medical needs
  • Cutting-edge products/pipeline with strong focus in innovative practices and processes
  • Global working environment with extensive communication with headquarters and other regional locations
  • Hybrid working style with extensive flexibility

職務内容

  • Take lead in the preparation, execution, and conducting audits internally/externally for the business to align the compliance of company standards and following GxP guidelines for clinical trials, policies, and procedures based on current local regulations
  • Evaluate any risk assessments for GxP operations based on company's risk-based audit planning
  • Identify any compliance issues and reporting
  • Outline any quality standards, quality manuals, and policies
  • Be part of and lead in preparation for any changes/adjustment for SOPs and guidelines
  • Prepare and understand any audit trends as well as providing audit advice for the business
  • Communicate with regulatory authorities (PMDA,MHLW) to support in regulatory inspections and reporting
  • Work with colleagues with other auditees
  • Be part of any training, conferences, associations to self improve in GxP area as well as obtain effective knowledge/information,

理想の人材

  • Extensive experience in the GCP QA area in a pharmaceutical environment
  • Strong understanding of GxPs, clinical operations, and other areas in a product's life cycle
  • High fluency in English and Japanese (non-native level speakers will not be selected)
  • Ability to work with 3rd party organisations ex. CROs, health authorities, etc.
  • Strong background in local regulations, guidelines, and compliance policies
  • University degree in a scientific or relevant area
  • Ability to travel both domestically and overseas
  • Experienced in conducting GCP audits

条件・待遇

  • Competitive salaries and benefits
  • Great work life balance
  • Hybrid working style
  • International environment
  • Great career development in clinical quality
  • Work with industry leaders who are solving various unmet medical needs
  • Ability to travel overseas
コンタクト
Zach Itozu
求人番号
JN-092023-6169552
電話
+813 6832 8683

求人情報

分野
ライフサイエンス
職種
製薬
業界
ヘルスケア・製薬
勤務地
日本
雇用形態
正社員
担当コンサルタント
Zach Itozu
担当コンサルタントの電話番号
+813 6832 8683
求人番号
JN-092023-6169552
企業タイプ
外資系企業

ダイバーシティ&インクルージョン

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