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Global Quality Compliance(GQC)

Quality and compliance are core values embedded in our culture to assure the biopharmaceutical products manufactured at WuXi Biologics are of the highest level of efficacy and safety per  our customers expectations. Global Quality Compliance (GQC) is committed to establishing and implementing the global quality system to assure consistency and execution across departments and sites in various countries. GQC currently houses five groups: -Global Quality System, Global Audit, IT Quality, Internal Compliance and Risk Analytics.

  • Quality Standards: Establishing and implementing Global PQS (Pharmaceutical Quality Systems) across sites.
  • Learning and Metrics: Providing global learning, quality metrics, and quality risk insights to the QLT (Quality, Lean, and Transformation) team
  • Change Control and CAPAs: Managing global and multi-site change controls and Corrective and Preventive Actions (CAPAs) for the network
  • Supply Quality Quality Service:

 

    • Quality Services: Enhancing quality service delivery throughout the customer journey.
    • Incident Management: Managing and resolving quality service-related incidents and escalation processes to align with organizational goals.
  • Oversight of Engineering and Validation and Testing activities: Providing quality oversight for Global Engineering (ENG) and Global Manufacturing Engineering Validation and Testing (MEVT) activities to ensure compliance with international and national regulations and guidelines.
  • Regulatory Compliance: Keeping up to date with regulatory changes impacting validation requirements and updating processes as needed.
  • Computer System Quality

 

    • Define and maintain CSQS (computerized system quality system), provide guidance for CSQS implementation across all sites.
    • Provide computerized system quality support for new sites.
    • Provide quality assurance for global computerized systems & IT infrastructure to make sure system validation and operation meet the regulation requirements.

 

  • Data Governance

 

    • Define and sustain data governance strategies, policies and framework
    • Implementing meaningful and effective strategies on data management and data integrity risks based on current regulatory expectations.
    • Align requirements and oversight on Quality System Software Applications (Trackwise and MasterControl) across sites