Our client is a global leader in the provision of OTC healthcare and wellness solutions worldwide. Playing a key role in the pharmaceutical and consumer health industries, they continue to expand due to unprecedented success.
They now require a Senior GMP Auditor to join their growing team, based out of their corporate HQ in Dublin, to support the planning, scheduling and conducting of external audits to ensure their business partners comply with the appropriate standards.
The Position
* Coordinate with the requesting site to collect relevant information about the audit and the products involved.
* Follow up with the auditee to arrange audit schedules and discuss the scope and logistical details of the audit.
* Expertly analyse audit data to identify any deviations from GxP standards accurately.
* Keep detailed audit records in Trackwise AIM when serving as the lead auditor.
* Manage audit requests in the Audit Plan, ensuring accurate tracking and documentation when serving as the lead auditor.
* Define and convey the audit scope, plan, and agenda when taking the lead auditor role.
* Efficiently organise time and tasks to ensure thorough preparation and smooth execution of audit activities.
* Prepare and submit audit and observation reports promptly.
* Review and evaluate audit observations and assess proposed corrective and preventive actions (CAPAs) with the requesting sites in a timely fashion.
* Lead projects around continuous improvement of Audit Systems.
The Person
* Degree qualification required, preferably Engineering or Science related.
* 5+ years working in a GxP-regulated industry (quality and/or auditing).
* Thorough knowledge of relevant legislation.
* Quality Auditor certification is preferable.
* Self-starter with strong analytical and interpersonal skills.
The Benefits
* Competitive market salary.
* Bonus, healthcare and pension.
* Significant career growth and opportunities.
To learn more about this opportunity, apply online or contact Treasa Prior at HRM Search Partners at +353 873983226, for a confidential discussion.
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