QP and EU Importation Manager
QP and EU Importation Manager x3 Positions:
GSK manages the batch certification and release of imported products for EU markets through an EU Importation hub that is part of the Quality Governance and Oversight team in GMS Quality. As part of planning activities for the UK exit from the European Union, an office is being set up in Dublin and there is a requirement to appoint a high-calibre individual into the key role of QP/EU Importation Manager.
The successful individual will be responsible for ensuring a compliant operation is in place to allow for EU certification of pharmaceutical products imported by the Principal Trading Companies (PTC) in line with the GMP aspects of the laws governing the importation of products into the EU.
The activities and responsibilities of this role will include;
• Ensuring a compliant operation is in place to allow for EU certification of batches of pharmaceutical products imported by the PTC operation
• Be a lead point of contact with non EU based GSK manufacturing sites and with GSK External Supply Quality and GMP Audit Group for products manufactured outside the EU to ensure that the requirements for QP certification are in place an maintained. Ensure the appropriate quality agreements are in place.
• Be a lead point of contact with R&D for new products being imported into Europe ensuring that a testing location is identified and resourced (if required) and QP certification and release activities meet the programme timelines
• Be a lead point of contact for Quality for imported products with the Europe Supply Chain hub
• Identify and support management of incidents as required, ensuring supply sites have all the information required to lead the investigation and incident resolution
• Ensure the EU Importation operation is inspection ready and lead/host regulatory inspections of the QP certification process on behalf of the PTC
• Be the owner of the PTC manufacturer importation authorisations [MIA] filed with the Irish HPRA
• Obtain the information required from the multimarket warehouses in Europe to support any QP certification decisions as applicable
• QP certify all batches of Pharma products imported into Europe, portfolio may be extended to cover multiple dose forms [- in which case systems and processes would be adapted to cover this]
• 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
• Perform audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation
• Actively represent EU Importation QP certification operations at Quality Councils as required
• Work directly with the named Responsible Person, MMW QPs, Move Product and EUSC Distribution to support management of any Quality Incidents associated with QP Certification
• Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
• Educate and train rest of GSK/ViiV organisation on the QP certification requirements ensuring compliance
• Where required develop the implementation of an alternative testing programme or provide oversight to the existing test arrangement to ensure EU product testing requirements are met for all products imported via the PTC arrangement into Europe. Manage the programme ensuring it is effectively budgeted, testing is completed to plan and issues are managed.
• Co-ordination with the PTC Quality Manager in the following areas; QMS implementation, Quality Councils, Controlled drug licences, Resource management
• Management of batch release specialist(s)
To be considered for this role you will be a Certified QP with experience in the certification of major dose forms [tablets, cream/ointments], aseptic sterile manufacture and biopharm products. You'll have been involved with or lead HPRA inspections and hold a broad knowledge of Quality, Manufacturer Importation/ Wholesaler Dealer licences and GDP. You may also be a qualified Auditor.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process..
Thank you for your interest in this opportunity.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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