GMP Auditor | Collins McNicholas

GMP Auditor

  • Reference: LK45127x
  • Job Type: Permanent
  • Location: Clare, Limerick, Tipperary
  • Category: Science, Pharmaceutical & Food

Collins McNicholas currently have an exciting opportunity for an GMP Auditor with one of their clients in the Mid-West Region. This role is a permanent position.

 

Role Summary: Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area

 

Responsibilities:

  • Schedules, prepares, and conducts audits in support of GMP as directed.
  • Assembles and coordinates the activities of the audit team.
  • Conducts audits in accordance with company standard operating procedures and quality policies.
  • Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
  • Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
  • Escalates any compliance issues.
  • Communicates audit results to management and auditees through written audit reports.
  • Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
  • Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
  • Drafts and issues periodic reports to site management as requested.
  • Assists with training/orientation for new Quality Auditing staff.
  • Supervises junior auditors
  • This position requires 40% travel

 

Requirements:

  • BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred.  Other relevant experience may be considered in lieu of degree.

 

 

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270

 


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Michael O'Leary

Contact Consultant

  • Michael O'Leary
  • Recruitment Consultant
  • 061 512273
  • Connect with Michael

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