Global Internal Quality Auditor - Gilbertsville, KY, United States - Neptune Enterprises

Neptune Enterprises
Neptune Enterprises
Verified Company
Gilbertsville, KY, United States

3 days ago

James Miller

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James Miller

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Freelance
Description

The Global Internal Quality Auditor at Gilbertsville, KY is responsible for conducting internal quality audits on a global scale and assisting the Director of Internal Audits in continuously improving the global audit systems.

This includes planning, evaluating, documenting, and adapting to industry and regulatory trends.


The audits cover various departments such as Manufacturing, Services, Sales and Marketing, and R&D, located around the world, and are conducted according to 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.


This position reports directly to the Director of Internal Audits and has the potential for future growth in terms of responsibility and hierarchy.

The role requires frequent travel, approximately 50%, sometimes on short notice.


Key Responsibilities:

Conduct Audits

  • Lead the planning and execution of internal quality audits in accordance with relevant international standards, local regulations, and Fresenius Kabi's global procedures.
  • Evaluate compliance of systems, processes, and procedures with audit criteria and document findings in audit reports.
  • Assess potential compliance risks, make riskbased decisions, and communicate with the auditee and Fresenius Kabi management.
  • Ensure timely issuance of audit reports and propose corrective/preventive actions to address identified deficiencies.
  • Conduct desktop audits.

Analyze Trends

  • Monitor trends in internal audits, authority findings, regulations, norms,
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