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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