Danielle Allen
About Candidate
Education
Bachelor of Civil Law (2.1) Various modules including Tort, Contract, EU, Land, Criminal, Jurisprudence
I work in Pharmaceutical QA and wanted to get a better understanding of supply chain management Introduction to basic principles of Supply Chain Management & Procurement. The course covered the concept of logistics, reverse logistics, supply chains, and supply chain vulnerability The value chain and its role in formulating business strategy. Additionally, the course looked at the impact that SCM has had on traditional purchasing management approaches and philosophies. Global trade and supply chain management and the importance of global infrastructure to optimal SCM. The online course consisted of lectures, break out modules and an essay topic. As this was post-Brexit, my topic was the difficulties Irish MAHs/Wholesaler faced when the UK left the EU and all finished medicinal product destined for Ireland, but which is manufactured and previously EU QP released in the UK, had to go to a site in the EU pending EU QP Testing and release. This caused logistical and supply chain issues. Medicines manufactured in the UK would have to be transported in a restricted status to an EU QP Testing/release site prior to onward supply to Ireland. (Distinction)
Attend regular GDP, HPRA & IPHA training
Work & Experience
GDP (Good Distribution Practice) Specialist - NPDs for Medicine (Human & Veterinary), Med Device, Cosmetic, Biocide etc - Supplier & Customer bona fides - Temperature excursion monitoring - Complaint Management (Product quality & distribution) & PV - Deviation, CAPA, Risk Management -Recall & Quarantine activities for IE market - Liaising with HPRA - EMP specialist for Allphar services and Uniphar - Controlled Drug Management (e.g. Licences, LONOs, export) - KPI manaement etc
QA Specialist for a Global Pharma company. We maintain a WDA for procure & supply activities only as we are MAH for various self-care products to the IE market. This entails ensuring compliance with HPRA guidance for Wholesaling and marketing activities. Also in scope of IPHA guidance. The role is incredibly varied as we are a global pharma company with multiple product portfolios, CMOs, customers, affiliates etc. - Maintaining WDA to ensure compliance to HPRA requirements & EU GDP Guidance 2013/c/343/01 - MAH oversight of products distributed to IE market -Complaints/PV/ AEs -Qualification lead for supplier, customer, outsourced suppliers/vendors - NPD specialist for new launches to IE marker (Liaise with QA, REG, Commercial, Sales & Marketing and other functions). New product set up requires QA and regulatory checks to ensure compliance including correct legal/supply status and this data must be recorded in SAP and in listings to ensure product traceability/integrity - Audits & Self Inspection - Recall management - Risk management - Deviation, CAPA & technical writing for non-conformities and risks to licences - KPI
