Harmonics are currently recruiting for a QA Auditor for leading a Limerick based multinational. The ideal candidate must be based in Ireland, but can work remotely and would need to be onsite in Limerick approx. once per quarter.
Summary: Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.
Essential Duties and Responsibilities include, but are not limited to, the following:
• 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.
• Ability to stand and walk for extended periods of time
***This position requires 50% travel***
Education and Experience:
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.