Danaher Corporation
Danaher Corporation
Danaher Corporation जीवन विज्ञान और निदान संबंधी प्रौद्योगिकियाँ विकसित करती है, जिनका उपयोग वैज्ञानिक अनुसंधान, जैव प्रौद्योगिकी और नैदानिक परीक्षणों में किया जाता है। इसके व्यवसाय शैक्षणिक संस्थानों, दवा और जैव प्रौद्योगिकी कंपनियों तथा नैदानिक प्रयोगशालाओं के लिए उपकरण, सॉफ़्टवेयर, प्रौद्योगिकियाँ और सेवाएँ उपलब्ध कराते हैं। कंपनी का ध्यान जैव प्रौद्योगिकी उपकरणों, निदान प्लेटफ़ॉर्मों और जीवन विज्ञान से जुड़े अन्य उत्पादों पर है। Danaher Business System के माध्यम से कंपनी अपने संचालन का प्रबंधन करती है और ऐसे अधिग्रहणों के जरिए अपने पोर्टफोलियो का विस्तार करती है, जो उसकी प्रौद्योगिकी और ग्राहक पहुंच को बढ़ाते हैं।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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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