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Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Senior GMP Auditor


Reference:POR/A005544ljp Location: Republic of Ireland
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Project Lead


Consistently ranked as a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies, our client offers a unique, world-class opportunity for interested candidates. An outstanding Senior GMP Auditor is required who is excited by a start-up environment and recognizes the opportunities that this offers and wants to be challenged. This role may be based remotely within the Republic of Ireland.

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 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 50% travel***

The Person


  • BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry
  • 2-5 years of audit experience in GMP environment


If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 87 70914141 / [email protected]