Quality Assurance Specialist

Walker-Cole-International-is-supporting-a-well-established-pharmaceutical-wholesale-distribution-organisation-in-the-search-for-a-Quality-Specialist-to-join-their-Quality-team,-based-in-Kent.

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-