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Job Order:

5430

Staff Representative:

Tim Jadwin

Position:

Auditor

Location:

Illinois

Company Summary:

A leading supplier of specialty and generic liquid pharmaceutical products.

Description:

Responsibilities:
Coordinate and perform all internal and external audits in compliance with Company SOPs and cGMP Regulations.

Typical Duties:

• Internal Audits
  • Prepare a schedule annually of all internal audits to be conducted through out the year.
  • Execute internal audits according to schedule and report findings.
  • Support departments in the development of corrective actions to audit findings.
• External Audits
  • Prepare a schedule annually of all external audits to be conducted through out the year.
  • Coordinate with suppliers to plan audit trips.
  • Execute external audits according to schedule, report findings, and provide guidance on the approval and disqualification of suppliers.
  • Review corrective action plans submitted by suppliers.
• General
  • Perform daily walk through audits of the manufacturing floor and other cGMP areas of the site.
  • Initiate Incident or Discrepancy Reports for any applicable non-conformances.
  • Perform other duties as assigned by the Manager of Quality Information.

Job Specifications:

• BS/BA degree in a scientific discipline
• A minimum of 4-5 years experience in a pharmaceutical industry
• A minimum of 2-3 years of auditing experience.
• Knowledge of cGMP, ICH and CFR guidelines

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