- 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
- 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
- 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