This is an excellent opportunity to join a GDP-regulated environment, working closely with the Responsible Person (RP) to ensure products are stored and distributed safely and in full compliance with EU GDP and HPRA requirements. The role offers broad, hands-on exposure across quality systems, complaints and deviations, supplier approval, self-inspections, training and regulatory inspections.
This role would suit a QA professional with at least one year's quality experience who is looking to build their GDP expertise, with the opportunity to deputise for the RP.
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.
* Supporting the monitoring and updating of Quality Agreements, and participating in risk assessments.
The successful candidate will have:
* At least one year's experience working in a quality department within the pharmaceutical industry.
* A good understanding of EU GDP guidelines and HPRA requirements.
* Experience handling deviations, CAPAs, change controls, complaints or returns.
* Experience with SOPs, document control and training records.
* Strong attention to detail, with excellent communication and organisational skills.
* The ability to work collaboratively across departments, with a proactive approach to continuous improvement.
Quality Specialist | Quality Assurance | QA | GDP | Good Distribution Practice | EU GDP | HPRA | Responsible Person | RP | Wholesale Distribution | WDA | Deviations | CAPA | Change Control | Supplier Approval | Self-Inspection | Recalls | Pharmaceutical
Salary description
£40000.00 - £45000.00 per year