Senior GMP Auditor needed for bio-pharmaceutical company in Limerick. All talented candidates are welcome to apply.
The Senior GMP Auditor is responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area..
Role of this position
- 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 Regeneron 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.
- BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry
- 2-5 years of audit experience in GMP environment preferred.
- This position requires 40% travel
Please call Mike Morrissey today for further information on 021-429 7536 or email: email@example.com
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