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Danaher Corporation
Danaher Corporation
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Danaher Corporation dezvoltă tehnologii pentru științele vieții și diagnostic, utilizate în cercetarea științifică, biotehnologie și testarea clinică. Companiile sale furnizează instrumente, software, tehnologii și servicii instituțiilor academice, companiilor farmaceutice și de biotehnologie și laboratoarelor clinice, cu accent pe instrumente de biotehnologie, platforme de diagnostic și alte produse pentru științele vieții. Compania își gestionează operațiunile prin Danaher Business System și își extinde portofoliul prin achiziții care îi dezvoltă tehnologiile și accesul la clienți.
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Locurile de muncă ale companiei

Clinical Compliance Auditor

Support clinical and vendor audits, NMPA inspections, and compliant clinical processes as a Clinical Compliance Auditor. Danaher helps customers worldwide address complex challenges in science and technology.

CNChinaLa sediuNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăAuditor

Descriere

  • Coordinate internal and external audits.
  • Help develop annual audit programs and schedules.
  • Lead or support site and sponsor clinical audits.
  • Evaluate clinical study compliance with applicable standards and regulations.
  • Prepare and distribute audit schedules, plans, and reports.
  • Review objective evidence and classify nonconformity findings.
  • Monitor audit findings and corrective actions through documented completion.
  • Create and maintain clinical and quality metrics.
  • Participate in NMPA inspections.
  • Manage vendor and supplier qualification from initiation through completion.
  • Develop compliant clinical processes.
  • Maintain and revise processes, procedures, and SOPs.
  • Help train Clinical Affairs staff on regulations, standards, requirements, processes, best practices, and SOPs.
  • Support clinical study teams and resolve clinical compliance issues.
  • Work with customers and global teams to address complex challenges and advance science and technology.

Cerințe

  • The source does not specify particular clinical compliance auditing qualifications or experience.
  • Working knowledge of applicable clinical standards and regulations.
  • Familiarity with NMPA inspections.
  • Ability to perform site, sponsor, vendor, and supplier audits.
  • Ability to qualify vendors and suppliers and conduct risk assessments.
  • Ability to develop and maintain clinical processes, metrics, procedures, and SOPs.
  • Ability to support clinical study teams and resolve clinical compliance issues.

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