Site Name: Ireland - Dublin
Posted Date: Jan 20 2025
Team introduction
The GSK QP Importation team (Trading Partner Quality) provides a service to the GSK Trading Partners to permit Importation and QP certification for release of GSK and ViiV finished products from outside of the EU into the EU and from outside the UK into the UK.
The product scope managed by the QP Importation team currently includes topical semi-solids, oral solids, solutions, suspensions, and sterile solution for infusion dosage forms manufactured in third country GSK and Contract manufacturing sites.
Position Summary
The Batch Release Specialist prepares product release dossiers for presentation to the QP Importation Qualified Persons (QPs). This involves review of batch manufacturing and packaging records, artwork, quality notifications, transportation and temperature records, sampling plans and test results.
The role also includes escalation of issues to manufacturing sites, warehouse teams and logistics groups that arise from the reviews to support batch certification processes.
The QP Importation team manages approximately 1000 batches per annum and this role is key to ensuring compliant release of batches.
In this role you will:
* Review batch and transport documentation, including Quality events such as deviations and consult with the manufacturing site and/or warehouse, and QPs to understand the impact of the deviation on product quality prior to release and certification – manage correspondence and communication between the parties to conclusion.
* Ensure records of batches certified are maintained, and dossiers and samples archived in accordance with local SOPs and GMP requirements.
* Liaise with the Importation warehouses and Testing Laboratories to ensure samples’ delivery, obtain testing data and work with laboratory to resolve any issues related to QC analyses of imported products.
* Conduct activities to support QP Importation processes related to quality oversight for importation, including:
* Periodic Quality Reviews for imported products.
* Generation and reporting of Key Performance metrics.
* Standard Operation procedures and technical report preparation, revision, and approval.
* Conduct/participate in self-inspections and management monitoring activities.
* Present data on GSK’s behalf during regulatory inspections of importation operations.
* Effectively communicate with Supply Chain Hubs, GSK Local Operating Companies, manufacturing sites, External Supply managers and Importation warehouses to provide information on progress of release and certification, as required.
Why you?
We are looking for professionals with these required skills and attributes to achieve our goals:
* Educated to Irish Leaving Certificate or UK GCSE/A Level standard (or equivalent). Preferably holds university degree in a relevant science subject e.g., Pharmacy, Chemistry, Biology, General Science.
* Preferably experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements.
* Understanding of quality management principles and documentation requirements for GMP compliance.
* Working knowledge of GMP and GDP regulations.
* Capable of working in multi-disciplinary teams across IT, Quality, External Supply, Global Logistics, Supply Chain and Manufacturing.
* Proficient in use of Microsoft Office applications.
* Preferably experienced in use of SAP, Veeva Vault, GLAMS systems.
Closing Date for Applications: 31st January 2025 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV 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.
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