Global Quality Auditor - Pownal, VT, United States - SilverLinx

SilverLinx
SilverLinx
Verified Company
Pownal, VT, United States

3 weeks ago

James Miller

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James Miller

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Freelance
Description

The Global Quality Auditor (M/F/d) in Pownal, VT is responsible for conducting internal quality audits on a global scale and assisting the Director of Internal Audits in continuously improving the audit systems to align with industry and regulatory trends.


These audits cover our Manufacturing, Services, Sales and Marketing, and R&D departments located around the world, ensuring compliance with external standards such as EU-GMP, FDA cGMP, Medical Device regulations, Pharmacovigilance regulations, ISO 9001, ISO 13485, and Fresenius Kabi's internal standards outlined in global SOPs.


Your responsibilities will include:

  • Conducting audits:
  • Leading the planning and execution of internal quality audits in accordance with international standards, local regulations, and Fresenius Kabi's global procedures
  • Evaluating the compliance of systems, processes, and procedures with relevant audit criteria, including global procedures, and documenting findings in audit reports
  • Assessing potential compliance risks, making riskbased decisions, and communicating them to the Auditee and Fresenius Kabi Management
  • Ensuring timely issuance of audit reports and proposing corrective/preventive actions to address identified deficiencies at their root cause
  • Conducting desktop audits
  • Evaluating trends in internal audits, regulatory findings, regulations, norms, and standards, and adapting the audit content/process accordingly
  • Sharing knowledge and providing training
  • Supporting the improvement of the Internal Audits Quality System
  • Managing various Internal Audits projects
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