Description:
In this role as EU/UK Importation Manager - QP you will provide a EU/UK batch certification and release service to the Principal Trading Companies [PTC] and Trading Partners, to ensure compliance with the GMP aspects of the laws governing the importation of products into the EU/UK. The scope of this role includes support to GSK Trading Services, GSK Export Ltd, Consumer Trading Services and ViiV Trading Services, and may be expanded to support other entities if created.
Key Responsibilities,
- Ensuring a compliant operation is in place to allow for EU/UK certification of batches of pharmaceutical products imported by the PTC operation
- Identify and support management of incidents as required, ensuring supply sites have all the information required to lead the investigation and incident resolution. EU/UK Importation team may be required to run LICs/PIRCs dependent on where the incident occurred.
- Ensure the EU/UK Importation operation is inspection ready and lead/host regulatory inspections of the QP certification process on behalf of the PTC.
- Ensure oversight of supply site operations via formal quality meetings with the site, involvement with internal audits undertaken at the sites and visits to view operations as required. Support regulatory inspections of supply sites, as required.
- Perform audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation, as required.
- Actively represent EU/UK Importation QP certification operations at Quality Councils and on assigned projects, as required.
- Educate and train wider GSK/ViiV organisation on the QP certification requirements ensuring compliance.
- QP certify all batches of Pharma products imported into EU/UK, portfolio may be extended to cover multiple dose forms
- Work directly with the named Responsible Person, MMW QPs, Global Logistics and EU/UK Supply Chain Distribution to support management of any Quality Incidents associated with QP Certification.
- Obtain the information required from the multimarket warehouses in EU/UK to support any QP certification decisions as applicable.
- Provide relevant information to the Consumer organisation to allow their nominated QPs to operate a compliant batch certification process in accordance with the MIA requirements.