药品质量体系高级专员

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  • 江苏省-无锡
  • Provide coordination and oversight of functional Quality & Compliance
  • Partnering in IMTs
  • Encourage function ownership of Quality
  • Sustain standard process for each PQS across site
  • Conduct Regulations and AZ global QCM compliance Evaluation
  • Agree PQS/GMP improvement priorities
  • Lead regulatory inspection preparations
  • Lead and coordinate Quality key systems in place and improvement, including, but not limited,
    • GMP training
    • Document management
    • QAA management
    • CAPA address, feedback and follow up
    • Change control
    • Quality risk management
    • Self-inspection
    • Complaint Management
  • KPI data collection and reporting to global
  • Quality performance review and reporting
  • Continuous improving on quality and compliance
  • Coordinate and lead GMP inspection from external heath authorities
  • Coordinate the communication with local healthy authority
  • Coordinate Site registration in China market.
  • Support CMCRC for site registration and product registration in global markets. 
  • Support China RA for product registration in China market.
  • Lead localization of global QCM to ensure comply with corporate quality
  • Lead intelligence of external regulation, provide compliance advise when necessary
  • Provide support on change management of QA E-system, eg. SAP, AZDoc, OCM, IDM， GCM etc.
  • SAP, AZDoc, OCM, IDM, GCM等