Raleigh - Auditing Consult - RTP, NC

placeRaleigh calendar_month 
Contract Auditor
  • Short Term Contract
  • RTP, North Carolina

RBW are partnering with a leading manufacturer of in vitro diagnostic medical devices, based in the RTP area. With over 17 years in industry experience, the company is well known for their innovation within Diagnostic products, and Contract Manufacturing services.

We are looking to speak with a detail-oriented and experienced Freelance Auditor to join our team for a short contract, focused on Supplier Auditing, Client Interfacing, and Statistical Analysis.

The ideal candidate will have a strong background in pharmaceutical manufacturing and a thorough understanding of regulatory requirements. This role involves conducting comprehensive audits to ensure compliance with industry standards and regulatory guidelines.

Key Responsibilities:

  • Conduct internal and external audits of pharmaceutical manufacturing processes.
  • Evaluate compliance with FDA, ISO 13485:2016, and other relevant regulatory standards.
  • Prepare detailed audit reports, highlighting areas of non-compliance and recommending corrective actions.
  • Collaborate with cross-functional teams to implement and monitor corrective and preventive actions (CAPAs).
  • Stay updated on industry trends and regulatory changes to ensure ongoing compliance.
  • Provide training and guidance to staff on quality and compliance matters.
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