You will be responsible for:

• Ensuring compliance with the Wholesale Distribution Authorisation, EU GDP Guidelines 2013/C 343/01 and HPRA requirements.
• Handling and escalating complaints, returns, deviations, CAPAs and change controls, ensuring they are recorded, investigated and closed in a timely manner.
• Managing supplier and customer approval processes and maintaining the approved lists.
• Managing SOPs, including implementing new procedures, tracking implementation and supporting annual documentation reviews.
• Maintaining the training matrix and delivering GDP and SOP training to staff.
• Preparing EU batch review documents for RP approval and release.
• Supporting the RP with product recalls, mock recalls, and the management of quarantined, returned, rejected and falsified medicines.
• Supporting preparation for, and participating in, regulatory and customer inspections and self-inspections.
• Collating quality KPIs and trends for Quality Management Review meetings.

You will be responsible for:

• Ensuring compliance with the Wholesale Distribution Authorisation, EU GDP Guidelines 2013/C 343/01 and HPRA requirements.
• Handling and escalating complaints, returns, deviations, CAPAs and change controls, ensuring they are recorded, investigated and closed in a timely manner.
• Managing supplier and customer approval processes and maintaining the approved lists.
• Managing SOPs, including implementing new procedures, tracking implementation and supporting annual documentation reviews.
• Maintaining the training matrix and delivering GDP and SOP training to staff.
• Preparing EU batch review documents for RP approval and release.
• Supporting the RP with product recalls, mock recalls, and the management of quarantined, returned, rejected and falsified medicines.
• Supporting preparation for, and participating in, regulatory and customer inspections and self-inspections.
• Collating quality KPIs and trends for Quality Management Review meetings.