Summary: Responsible for planning, coordinating and performing pre-, during and post-audit activities for assigned audits. Responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and Quality audits that may impact operations and/or product. The successful candidate can work remotely from anywhere within Ireland.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Maintains professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.).
- Monitors industry trends with respect to regulatory agency findings, expectations and warning letters.
- Performs supplier/external audits and evaluates systems, processes, procedures and records against applicable U.S. and ex-U.S. audit criteria as stated above.
- Collaborates with Procurement, External Manufacturing, Quality, audit clients and other partners with respect to supplier/external audits.
- Performs all audit activities for assigned audits when acting as lead auditor; leads and coordinates all audit activities and the audit team when assigned as the lead auditor on an audit team.
- Supports the lead auditor in all audit activities when assigned as a support auditor on an audit team.
- Ensures written and departmental procedures, timelines and requirements are followed and met.
- Prepares written audit documents and reports; ensures the quality and accuracy of all audit documentation.
- Provides guidance and support in the development of both corrective and preventive actions based on GxP requirements and industry standards.
- Performs peer reviews of audit documentation and auditee responses; ensures requirements for audit documentation and auditee responses are met.
- Participates in IOPS inspection readiness and inspections/partner audits, as needed.
- Performs and/or hosts internal audits of IOPS facilities, as needed.
- Assists with the oversight, selection, training, onboarding and/or consultant auditor performance assessments, as assigned by management.
- Performs and maintains all required training and annual GMP training within required timelines.
- Handles the training and qualification of auditors, as assigned by management.
- Participates in the development and maintenance of department processes and procedures to ensure compliance with current regulatory requirements.
- Assists management with training auditors to assess the acceptability of auditee responses and ensuring audit findings are classified appropriately, as assigned.
- Assists management with assessing auditee responses for acceptability and audit closure, as assigned.
- Assists management with development and maintenance of the auditor continuing education program.
- ***This position requires 50% travel***
Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences and 8 years of related experience in Quality Management in a Biotech/Pharmaceutical GMP environment, including prior auditing experience, or equivalent combination of education and experience.
- Or MSc & 7 years related experience as above
- Experience in aseptic filling operations preferred.